Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer

May 1, 2026 updated by: Children's Oncology Group

Triptorelin and Protection of Ovarian Reserve in Adolescents and Young Adults With Cancer

This phase III trial compares the effect of giving triptorelin vs no triptorelin in preventing ovarian damage in adolescents and young adults (AYAs) with cancer receiving chemotherapy with an alkylating agents. Alkylating agents are part of standard chemotherapy, but may cause damage to the ovaries. If the ovaries are not working well or completely shut down, then it will be difficult or impossible to get pregnant in the future. Triptorelin works by blocking certain hormones and causing the ovaries to slow down or pause normal activity. The triptorelin used in this study stays active in the body for 24 weeks or about 6 months after a dose is given. After triptorelin is cleared from the body, the ovaries resume normal activities. Adding triptorelin before the start of chemotherapy treatment may reduce the chances of damage to the ovaries.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the feasibility of conducting a cross network, multi-site, randomized clinical trial of triptorelin among newly diagnosed adolescent and young adult (AYA) female cancer patients age < 40 years (exclusive of breast cancer).

II. Measure ovarian reserve via anti-Mullerian hormone (AMH) at 2-years post completion of alkylating agent-containing chemotherapy among randomized patients.

SECONDARY OBJECTIVES:

I. Collect information on the longitudinal trajectory of change in AMH and other ovarian hormone levels from cancer diagnosis to 2 years post cancer treatment completion among randomized patients.

II. Determine the feasibility of measuring estrogen deprivation symptoms (i.e., hot flashes, sexual dysfunction) menstrual pattern, and quality of life among randomized patients.

EXPLORATORY OBJECTIVE:

I. Establish a unique cohort of female AYA patients treated with alkylating agent chemotherapy and randomized to receive or not receive triptorelin, that can be followed long-term to study reproductive health concerns and outcomes as well as genetic risk factors for premature menopause.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive triptorelin intramuscularly (IM) up to 14 days prior to standard chemotherapy. For patients whose chemotherapy exceeds 24 weeks, a second dose of triptorelin may be given 24 weeks after the first dose at the treating physician's discretion. Patients also undergo blood sample collection throughout the study.

ARM B: Patients receive standard chemotherapy. Patients also undergo blood sample collection throughout the study.

After completion of study treatment, patients are followed up at 1 and 2 years.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Québec, Canada, G1V 4G2
        • Recruiting
        • CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
        • Principal Investigator:
          • Bruno Michon
        • Contact:
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Recruiting
        • CancerCare Manitoba
        • Contact:
        • Principal Investigator:
          • Stephanie M. Villeneuve
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
        • Recruiting
        • The Montreal Children's Hospital of the MUHC
        • Contact:
        • Principal Investigator:
          • Stephanie Mourad
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • Children's Hospital of Alabama
        • Contact:
        • Principal Investigator:
          • Jamie M. Aye
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham Cancer Center
        • Principal Investigator:
          • Vanessa Eulo
        • Contact:
      • Mobile, Alabama, United States, 36604
        • Recruiting
        • USA Health Strada Patient Care Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-388-8721
        • Principal Investigator:
          • Hamayun Imran
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Phoenix Childrens Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 602-546-0920
        • Principal Investigator:
          • Alexandra M. Walsh
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Recruiting
        • Mercy Hospital Fort Smith
        • Contact:
          • Site Public Contact
          • Phone Number: 800-378-9373
        • Principal Investigator:
          • Jay W. Carlson
      • Little Rock, Arkansas, United States, 72202-3591
        • Recruiting
        • Arkansas Children's Hospital
        • Principal Investigator:
          • Michael W. Bishop
        • Contact:
          • Site Public Contact
          • Phone Number: 501-364-7373
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • CARTI Cancer Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Principal Investigator:
          • Rusha Bhandari
        • Contact:
      • La Jolla, California, United States, 92093
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Contact:
        • Principal Investigator:
          • H. I. Su
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 909-558-4050
        • Principal Investigator:
          • Albert Kheradpour
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Mattel Children's Hospital UCLA
        • Contact:
          • Site Public Contact
          • Phone Number: 310-825-6708
        • Principal Investigator:
          • Satiro N. De Oliveira
      • Oakland, California, United States, 94611
        • Recruiting
        • Kaiser Permanente-Oakland
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Aarati V. Rao
      • Orange, California, United States, 92868
        • Recruiting
        • Children's Hospital of Orange County
        • Contact:
        • Principal Investigator:
          • Elyssa M. Rubin
      • Sacramento, California, United States, 95816
      • San Diego, California, United States, 92123
        • Recruiting
        • Rady Children's Hospital - San Diego
        • Contact:
          • Site Public Contact
          • Phone Number: 858-966-5934
        • Principal Investigator:
          • William D. Roberts
      • San Diego, California, United States, 92103
        • Suspended
        • UC San Diego Medical Center - Hillcrest
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado
        • Principal Investigator:
          • Jenna M. Demedis
        • Contact:
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
        • Contact:
        • Principal Investigator:
          • Florence Choo
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Recruiting
        • Connecticut Children's Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 860-545-9981
        • Principal Investigator:
          • Michael S. Isakoff
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Recruiting
        • Beebe Medical Center
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Millville, Delaware, United States, 19967
        • Recruiting
        • Beebe South Coastal Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Helen F Graham Cancer Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Medical Oncology Hematology Consultants PA
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19718
        • Recruiting
        • Christiana Care Health System-Christiana Hospital
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Rehoboth Beach, Delaware, United States, 19971
        • Recruiting
        • Beebe Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Wilmington, Delaware, United States, 19803
        • Recruiting
        • Alfred I duPont Hospital for Children
        • Contact:
        • Principal Investigator:
          • Vibhuti Agarwal
      • Wilmington, Delaware, United States, 19801
        • Recruiting
        • Christiana Care Health System-Wilmington Hospital
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • Children's National Medical Center
        • Principal Investigator:
          • Jeffrey S. Dome
        • Contact:
    • Florida
      • Fort Myers, Florida, United States, 33908
        • Recruiting
        • Golisano Children's Hospital of Southwest Florida
        • Contact:
        • Principal Investigator:
          • Emad K. Salman
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • UF Health Cancer Institute - Gainesville
        • Contact:
        • Principal Investigator:
          • Brian Stover
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 954-265-1847
          • Email: OHR@mhs.net
        • Principal Investigator:
          • Iftikhar Hanif
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Nemours Children's Clinic-Jacksonville
        • Contact:
        • Principal Investigator:
          • Vibhuti Agarwal
      • Miami, Florida, United States, 33155
        • Recruiting
        • Nicklaus Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 888-624-2778
        • Principal Investigator:
          • Maggie E. Fader
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Meghan McCormick
      • Miami, Florida, United States, 33176
        • Recruiting
        • Miami Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 786-596-2000
        • Principal Investigator:
          • Doured Daghistani
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Nemours Children's Hospital
        • Contact:
        • Principal Investigator:
          • Vibhuti Agarwal
      • Orlando, Florida, United States, 32803
        • Recruiting
        • AdventHealth Orlando
        • Contact:
        • Principal Investigator:
          • Fouad M. Hajjar
      • Pensacola, Florida, United States, 32504
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General Hospital
        • Contact:
        • Principal Investigator:
          • Andrew J. Galligan
      • Tampa, Florida, United States, 33607
        • Active, not recruiting
        • Saint Joseph's Hospital/Children's Hospital-Tampa
      • West Palm Beach, Florida, United States, 33407
        • Recruiting
        • Saint Mary's Medical Center
        • Principal Investigator:
          • Matthew D. Ramirez
        • Contact:
          • Site Public Contact
          • Phone Number: 561-822-4745
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Children's Healthcare of Atlanta - Arthur M Blank Hospital
        • Principal Investigator:
          • Lillian R. Meacham
        • Contact:
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Recruiting
        • Kapiolani Medical Center for Women and Children
        • Contact:
          • Site Public Contact
          • Phone Number: 808-983-6090
        • Principal Investigator:
          • Wade T. Kyono
    • Illinois
      • Alton, Illinois, United States, 62002
        • Recruiting
        • OSF Saint Anthony's Health Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 618-463-5623
      • Aurora, Illinois, United States, 60504
        • Suspended
        • Rush-Copley Medical Center
      • Centralia, Illinois, United States, 62801
        • Suspended
        • Saint Mary's Hospital
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Lurie Children's Hospital-Chicago
        • Principal Investigator:
          • Jennifer L. Reichek
        • Contact:
          • Site Public Contact
          • Phone Number: 773-880-4562
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois
        • Contact:
          • Site Public Contact
          • Phone Number: 312-355-3046
        • Principal Investigator:
          • Dipti S. Dighe
      • Danville, Illinois, United States, 61832
        • Suspended
        • Carle at The Riverfront
      • Effingham, Illinois, United States, 62401
        • Suspended
        • Carle Physician Group-Effingham
      • Mattoon, Illinois, United States, 61938
        • Suspended
        • Carle Physician Group-Mattoon/Charleston
      • Mount Vernon, Illinois, United States, 62864
        • Recruiting
        • SSM Health Good Samaritan
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Normal, Illinois, United States, 61761
        • Recruiting
        • Carle BroMenn Medical Center
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Normal, Illinois, United States, 61761
        • Recruiting
        • Carle Cancer Institute Normal
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Oak Lawn, Illinois, United States, 60453
        • Recruiting
        • Advocate Children's Hospital-Oak Lawn
        • Contact:
          • Site Public Contact
          • Phone Number: 847-723-7570
        • Principal Investigator:
          • Rebecca E. McFall
      • Park Ridge, Illinois, United States, 60068
      • Shiloh, Illinois, United States, 62269
        • Recruiting
        • Memorial Hospital East
        • Contact:
        • Principal Investigator:
          • Nancy L. Bartlett
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Contact:
          • Site Public Contact
          • Phone Number: 217-545-7929
        • Principal Investigator:
          • Gregory P. Brandt
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Saint John's Hospital
        • Principal Investigator:
          • Gregory P. Brandt
        • Contact:
      • Urbana, Illinois, United States, 61801
        • Suspended
        • Carle Cancer Center
      • Yorkville, Illinois, United States, 60560
        • Suspended
        • Rush-Copley Healthcare Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Hospital for Children
        • Contact:
          • Site Public Contact
          • Phone Number: 800-248-1199
        • Principal Investigator:
          • Amanda Saraf
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University/Melvin and Bren Simon Cancer Center
        • Contact:
        • Principal Investigator:
          • Tarah J. Ballinger
    • Iowa
      • Ankeny, Iowa, United States, 50023
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Carroll, Iowa, United States, 51401
        • Recruiting
        • Saint Anthony Regional Hospital
        • Contact:
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Clive, Iowa, United States, 50325
        • Recruiting
        • Mercy Cancer Center-West Lakes
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Clive, Iowa, United States, 50325
        • Recruiting
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Creston, Iowa, United States, 50801
        • Recruiting
        • Greater Regional Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Broadlawns Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 515-282-2200
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Mercy Medical Center - Des Moines
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Blank Children's Hospital
        • Contact:
        • Principal Investigator:
          • Samantha L. Mallory
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Iowa Methodist Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-6727
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Fort Dodge, Iowa, United States, 50501
        • Recruiting
        • UI Healthcare Mission Cancer and Blood - Fort Dodge
        • Principal Investigator:
          • Seema Harichand-Herdt
        • Contact:
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa/Holden Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-237-1225
        • Principal Investigator:
          • Andrew P. Groves
      • Pella, Iowa, United States, 50219
        • Recruiting
        • UI Healthcare Mission Cancer and Blood - Pella
        • Principal Investigator:
          • Seema Harichand-Herdt
        • Contact:
      • Waukee, Iowa, United States, 50263
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • Mercy Medical Center-West Lakes
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • The Iowa Clinic PC
        • Principal Investigator:
          • Seema Harichand-Herdt
        • Contact:
          • Site Public Contact
          • Phone Number: 515-875-9815
    • Kansas
      • Garden City, Kansas, United States, 67846
        • Recruiting
        • Central Care Cancer Center - Garden City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Great Bend, Kansas, United States, 67530
        • Recruiting
        • Central Care Cancer Center - Great Bend
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Children's Hospital
        • Contact:
        • Principal Investigator:
          • Michael J. Ferguson
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
        • Recruiting
        • Children's Hospital New Orleans
        • Principal Investigator:
          • Maria C. Velez-Yanguas
        • Contact:
          • Site Public Contact
          • Phone Number: 504-894-5377
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Medical Center Jefferson
        • Contact:
        • Principal Investigator:
          • Craig Lotterman
    • Maine
      • Scarborough, Maine, United States, 04074
        • Recruiting
        • Maine Children's Cancer Program
        • Principal Investigator:
          • Ashley M. Jean
        • Contact:
      • Scarborough, Maine, United States, 04074
        • Recruiting
        • MaineHealth Maine Medical Center- Scarborough
        • Principal Investigator:
          • Ashley M. Jean
        • Contact:
    • Maryland
      • Bethesda, Maryland, United States, 20889-5600
        • Recruiting
        • Walter Reed National Military Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 301-319-2100
        • Principal Investigator:
          • Kip R. Hartman
      • Elkton, Maryland, United States, 21921
        • Recruiting
        • Christiana Care - Union Hospital
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • C S Mott Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 800-865-1125
        • Principal Investigator:
          • Jennifer E. Agrusa
      • Ann Arbor, Michigan, United States, 48109
        • Suspended
        • University of Michigan Rogel Cancer Center
      • Battle Creek, Michigan, United States, 49017
        • Recruiting
        • Bronson Battle Creek
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Trinity Health Grand Rapids Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • Bronson Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • West Michigan Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, United States, 49009
        • Recruiting
        • Beacon Kalamazoo Cancer Center
        • Principal Investigator:
          • Kathleen Y. Butler
        • Contact:
          • Site Public Contact
          • Phone Number: 574-647-7370
      • Kalamazoo, Michigan, United States, 49048
        • Recruiting
        • Beacon Kalamazoo
        • Principal Investigator:
          • Kathleen Y. Butler
        • Contact:
          • Site Public Contact
          • Phone Number: 574-647-7370
      • Muskegon, Michigan, United States, 49444
        • Recruiting
        • Trinity Health Muskegon Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Niles, Michigan, United States, 49120
        • Recruiting
        • Corewell Health Lakeland Hospitals - Niles Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 616-391-1230
        • Principal Investigator:
          • Kathleen Y. Butler
      • Norton Shores, Michigan, United States, 49444
        • Recruiting
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Reed City, Michigan, United States, 49677
        • Recruiting
        • Corewell Health Reed City Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Saint Joseph, Michigan, United States, 49085
        • Recruiting
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Saint Joseph, Michigan, United States, 49085
        • Recruiting
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Traverse City, Michigan, United States, 49684
        • Recruiting
        • Munson Medical Center
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • University of Michigan Health - West
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Recruiting
        • Children's Hospitals and Clinics of Minnesota - Minneapolis
        • Principal Investigator:
          • Michael K. Richards
        • Contact:
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota/Masonic Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 612-624-2620
        • Principal Investigator:
          • Karim T. Sadak
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center
        • Principal Investigator:
          • Betty L. Herrington
        • Contact:
          • Site Public Contact
          • Phone Number: 601-815-6700
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Recruiting
        • Mercy Oncology and Hematology - Clayton-Clarkson
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 888-446-3729
      • Bolivar, Missouri, United States, 65613
        • Recruiting
        • Central Care Cancer Center - Bolivar
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Branson, Missouri, United States, 65616
        • Recruiting
        • Cox Cancer Center Branson
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Mercy Cancer Center - Cape Girardeau
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 888-446-3729
      • City of Saint Peters, Missouri, United States, 63376
        • Recruiting
        • Siteman Cancer Center at Saint Peters Hospital
        • Principal Investigator:
          • Nancy L. Bartlett
        • Contact:
      • Creve Coeur, Missouri, United States, 63141
        • Recruiting
        • Siteman Cancer Center at West County Hospital
        • Principal Investigator:
          • Nancy L. Bartlett
        • Contact:
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Freeman Health System
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Mercy Hospital Joplin
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Hospitals and Clinics
        • Principal Investigator:
          • Keith J. August
        • Contact:
      • Osage Beach, Missouri, United States, 65065
        • Recruiting
        • Lake Regional Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Mercy Clinic-Rolla-Cancer and Hematology
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 573-458-6379
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Phelps Health Delbert Day Cancer Institute
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Saint Joseph, Missouri, United States, 64506
        • Recruiting
        • Heartland Regional Medical Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Mercy Hospital Springfield
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • CoxHealth South Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Principal Investigator:
          • Nancy L. Bartlett
        • Contact:
      • St Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy Hospital South
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
      • St Louis, Missouri, United States, 63129
        • Recruiting
        • Siteman Cancer Center-South County
        • Principal Investigator:
          • Nancy L. Bartlett
        • Contact:
      • St Louis, Missouri, United States, 63136
        • Recruiting
        • Siteman Cancer Center at Christian Hospital
        • Principal Investigator:
          • Nancy L. Bartlett
        • Contact:
      • St Louis, Missouri, United States, 63109
        • Recruiting
        • Mercy Infusion Center - Chippewa
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 888-446-3729
      • Washington, Missouri, United States, 63090
        • Recruiting
        • Mercy Hospital Washington
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 636-390-1600
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Children's Hospital and Medical Center of Omaha
        • Contact:
          • Site Public Contact
          • Phone Number: 402-955-3949
        • Principal Investigator:
          • Jill C. Beck
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Jill C. Beck
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Principal Investigator:
          • Burton E. Appel
        • Contact:
          • Site Public Contact
          • Phone Number: 551-996-2897
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Recruiting
        • University of New Mexico Cancer Center
        • Contact:
        • Principal Investigator:
          • Jessica M. Valdez
      • Albuquerque, New Mexico, United States, 87106
        • Recruiting
        • Presbyterian Hospital
        • Contact:
        • Principal Investigator:
          • Beeling Armijo
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 518-262-5513
        • Principal Investigator:
          • Lauren R. Weintraub
      • New York, New York, United States, 10032
        • Recruiting
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
        • Principal Investigator:
          • Nobuko Hijiya
        • Contact:
      • New York, New York, United States, 10065
        • Recruiting
        • NYP/Weill Cornell Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 212-746-1848
        • Principal Investigator:
          • Alexander J. Chou
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 585-275-5830
        • Principal Investigator:
          • Rafi R. Kazi
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-862-2215
        • Principal Investigator:
          • Laura E. Hogan
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center - Moses Campus
        • Contact:
        • Principal Investigator:
          • Alice Lee
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Lineberger Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Thomas B. Alexander
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • Jessica M. Sun
        • Contact:
          • Site Public Contact
          • Phone Number: 888-275-3853
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:
          • Site Public Contact
          • Phone Number: 336-713-6771
        • Principal Investigator:
          • Sarah Supples
    • North Dakota
      • Fargo, North Dakota, United States, 58122
    • Ohio
      • Akron, Ohio, United States, 44308
        • Recruiting
        • Children's Hospital Medical Center of Akron
        • Contact:
          • Site Public Contact
          • Phone Number: 330-543-3193
        • Principal Investigator:
          • Erin Wright
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Matteo M. Trucco
      • Columbus, Ohio, United States, 43205
      • Dayton, Ohio, United States, 45404
        • Recruiting
        • Dayton Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 800-228-4055
        • Principal Investigator:
          • Jordan M. Wright
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Rene Y. McNall-Knapp
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Mercy Hospital Oklahoma City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 405-752-3402
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
        • Principal Investigator:
          • Susan J. Lindemulder
    • Pennsylvania
      • Chadds Ford, Pennsylvania, United States, 19317
        • Recruiting
        • Christiana Care Health System-Concord Health Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 717-531-6012
        • Principal Investigator:
          • Lisa M. McGregor
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Principal Investigator:
          • Jill P. Ginsberg
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19134
        • Recruiting
        • Saint Christopher's Hospital for Children
        • Contact:
          • Site Public Contact
          • Phone Number: 215-427-8991
        • Principal Investigator:
          • Gregory E. Halligan
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • Children's Hospital of Pittsburgh of UPMC
        • Contact:
        • Principal Investigator:
          • Jean M. Tersak
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
        • Principal Investigator:
          • Bradley DeNardo
        • Contact:
          • Site Public Contact
          • Phone Number: 401-444-1488
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Recruiting
        • Prisma Health Richland Hospital
        • Principal Investigator:
          • Stuart L. Cramer
        • Contact:
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117-5134
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • Saint Jude Children's Research Hospital
        • Contact:
        • Principal Investigator:
          • Kari Bjornard
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University/Ingram Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-811-8480
        • Principal Investigator:
          • Elizabeth J. Davis
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • The Children's Hospital at TriStar Centennial
        • Contact:
          • Site Public Contact
          • Phone Number: 615-342-1919
        • Principal Investigator:
          • Clinton M. Carroll
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Principal Investigator:
          • Ksenya Shliakhtsitsava
        • Contact:
      • Dallas, Texas, United States, 75235
        • Recruiting
        • Parkland Memorial Hospital
        • Principal Investigator:
          • Ksenya Shliakhtsitsava
        • Contact:
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Medical City Dallas Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 972-566-5588
        • Principal Investigator:
          • Maurizio L. Ghisoli
      • El Paso, Texas, United States, 79905
        • Recruiting
        • El Paso Children's Hospital
        • Contact:
        • Principal Investigator:
          • Benjamin Carcamo
      • Fort Worth, Texas, United States, 76104
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Najat C. Daw
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 713-798-1354
          • Email: burton@bcm.edu
        • Principal Investigator:
          • Stephanie Fetzko
      • San Antonio, Texas, United States, 78207
        • Recruiting
        • Children's Hospital of San Antonio
        • Contact:
        • Principal Investigator:
          • Julie Voeller
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • VCU Massey Comprehensive Cancer Center
        • Principal Investigator:
          • Jordyn R. Griffin
        • Contact:
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Carilion Children's
        • Contact:
        • Principal Investigator:
          • Erwood G. Edwards
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 866-987-2000
        • Principal Investigator:
          • Sarah E. Leary
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center - Montlake
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-8824
        • Principal Investigator:
          • Eric J. Chow
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-8824
        • Principal Investigator:
          • Eric J. Chow
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Providence Sacred Heart Medical Center and Children's Hospital
        • Contact:
        • Principal Investigator:
          • Judy L. Felgenhauer
      • Tacoma, Washington, United States, 98431
        • Recruiting
        • Madigan Army Medical Center
        • Principal Investigator:
          • Melissa A. Forouhar
        • Contact:
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • Recruiting
        • Saint Vincent Hospital Cancer Center Green Bay
        • Principal Investigator:
          • Catherine A. Long
        • Contact:
      • Green Bay, Wisconsin, United States, 54303
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Saint Mary's
        • Principal Investigator:
          • Catherine A. Long
        • Contact:
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Carbone Cancer Center - University Hospital
        • Contact:
        • Principal Investigator:
          • Cathy A. Lee-Miller
      • Madison, Wisconsin, United States, 53718
        • Recruiting
        • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
        • Contact:
        • Principal Investigator:
          • Cathy A. Lee-Miller
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Children's Hospital of Wisconsin
        • Principal Investigator:
          • Kerri Becktell
        • Contact:
      • Milwaukee, Wisconsin, United States, 53233
        • Recruiting
        • Aurora Sinai Medical Center
        • Contact:
        • Principal Investigator:
          • Rebecca E. McFall
      • Oconto Falls, Wisconsin, United States, 54154
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Oconto Falls
        • Principal Investigator:
          • Catherine A. Long
        • Contact:
      • Sheboygan, Wisconsin, United States, 53081
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Sheboygan
        • Principal Investigator:
          • Catherine A. Long
        • Contact:
      • Sheboygan, Wisconsin, United States, 53081
        • Recruiting
        • Sheboygan Physicians Group
        • Principal Investigator:
          • Catherine A. Long
        • Contact:
      • Sturgeon Bay, Wisconsin, United States, 54235-1495
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
        • Principal Investigator:
          • Catherine A. Long
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • < 40 years of age at the time of enrollment
  • Patient must be a post-menarchal female and report that their initial menstrual period occurred > 6 months prior to enrollment. (Current menstrual status is not part of the inclusion criteria.)

  • Newly diagnosed with first cancer, exclusive of breast cancer.

    • Note: Apart from breast carcinoma, other tumor types originating in the breast are permitted (e.g., sarcoma, lymphoma).
  • Planned treatment must include one or more of the following alkylating agents delivered with curative intent: cyclophosphamide, ifosfamide, procarbazine, chlorambucil, carmustine (BCNU), lomustine (CCNU), melphalan, thiotepa, busulfan, nitrogen mustard.
  • For patients < 20 years of age at enrollment, the expected alkylator dose must be ≥ 4 g/m^2 cumulative cyclophosphamide equivalent dose (CED). For patients ≥ 20 years of age at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators that contribute to CED.
  • All patients and/or their parents or legal guardians must sign a written informed consent.
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.

Exclusion Criteria:

  • Any planned radiation to the pelvis; or cranial radiation ≥ 30 gray (Gy) to the hypothalamus, inclusive of any total body irradiation (TBI).
  • Planned bilateral oophorectomy. Note: A participant's desire to pursue alternative fertility preservation procedures (i.e., embryo, oocyte, or ovarian tissue cryopreservation) will be allowed (and in fact encouraged).
  • Congenital syndromes associated with infertility and decreased ovarian reserve at baseline. For example: Turner's Syndrome, Fragile X premutation carriers, Down syndrome, etc.
  • Pre-existing seizure disorder, congenital long QT syndrome, pseudotumor cerebri; history of pulmonary embolism, venous thrombosis, or myocardial infarction. Note: Contact study chairs if questions arise about other pre-existing conditions.
  • Receipt of long acting (depot) GnRH agonists within 6 months before enrollment. In contrast, subcutaneous GnRH agonist used for oocyte retrieval is not an exclusion; oral and other hormonal contraceptive use is also not an exclusion. Note: Please see protocol for the concomitant therapy restrictions for patients during the study treatment period. See protocol for information about oral and other hormonal contractive use during the study treatment period.
  • Prior receipt of systemic chemotherapy. However, steroids and intrathecal chemotherapy are permitted prior to study enrollment.
  • Any prior radiation to the pelvis; or cranial radiation ≥ 30 Gy to the hypothalamus, inclusive of any total body irradiation (TBI).
  • Patients who are pregnant are not eligible. A pregnancy test is required for female patients of childbearing potential.
  • Lactating females who plan to breastfeed their infants for the duration of triptorelin therapy (24 weeks per dose).
  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of triptorelin therapy (24 weeks per dose).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A (triptorelin)
Patients receive triptorelin IM up to 14 days prior to standard chemotherapy. For patients whose chemotherapy exceeds 24 weeks, a second dose of triptorelin may be given 24 weeks after the first dose at the treating physician's discretion. Patients also undergo blood sample collection throughout the study.
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Other: Survey Administration
Ancillary studies
Other: Electronic Health Record Review
Ancillary studies
Drug: Triptorelin Pamoate
Given IM
Other Names:
  • Decapeptyl
  • Trelstar
  • Pamorelin
  • Diphereline
  • Triptorelin Embonate
Active Comparator: Arm B (usual care)
Patients receive standard chemotherapy. Patients also undergo blood sample collection throughout the study.
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Other: Survey Administration
Ancillary studies
Other: Electronic Health Record Review
Ancillary studies
Other: Best Practice
Receive standard chemotherapy
Other Names:
  • standard of care
  • standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-mullerian hormone (AMH) levels
Time Frame: At 2 years post-chemotherapy
AMH values will be examined to confirm that the combined variability of AMH in both arms is consistent with our a priori assumptions.
At 2 years post-chemotherapy
Number of enrollments of newly diagnosed AYA female cancer patients age < 40 years
Time Frame: Up to 2 years post-chemotherapy
Number of enrollments by the end of the DOD funded grant period, and ideally prior to Year 4 to enable greater duration of follow-up time. Will help determine if a larger efficacy study can be successfully completed as a cross network trial in a reasonable funding period.
Up to 2 years post-chemotherapy
Accrual rates of newly diagnosed AYA female cancer patients age < 40 years
Time Frame: Up to 2 years post-chemotherapy
Accrual rates of newly diagnosed AYA female cancer patients age < 40 years. Over the second half of the funding period, demonstrate a positive trajectory in accrual rates that provides data to inform future funding proposals that would seek to complete the overall larger study within a typical 5-year funding period.
Up to 2 years post-chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Longitudinal AMH along with other ovarian hormone levels
Time Frame: Up to 2 years post-chemotherapy
These measurements will help inform rates of missingness. Will be used to estimate the longitudinal trajectory of change in these hormones by triptorelin randomization status.
Up to 2 years post-chemotherapy
Estrogen deprivation symptoms: Hot flashes
Time Frame: Up to 2 years post-chemotherapy
Estrogen deprivation symptoms include hot flashes. The Patient-Reported Outcomes version of the Common Terminology for Adverse Events (PRO-CTCAE) will be used to collect information on the frequency and interference of hot flashes.
Up to 2 years post-chemotherapy
Estrogen deprivation symptoms: Vaginal/vulvar symptoms
Time Frame: Up to 2 years post-chemotherapy
Estrogen deprivation symptoms include vaginal/vulvar symptoms. The Patient-Reported Outcomes version of the Common Terminology for Adverse Events (PRO-CTCAE) will be used to collect information on the frequency and interference of vaginal/vulvar symptoms. The PROMIS Sexual Function and Satisfaction version (v) 2.0 Brief Profile - Female (PROMIS SexFS) will be used to evaluate vaginal and vulvar discomfort, pain, and lubrication.
Up to 2 years post-chemotherapy
Estrogen deprivation symptoms: Sexual function
Time Frame: Up to 2 years post-chemotherapy
Estrogen deprivation symptoms include sexual function. The Patient-Reported Outcomes version of the Common Terminology for Adverse Events (PRO-CTCAE) will be used to collect information on the frequency and interference of sexual function. The PROMIS Sexual Function and Satisfaction version (v) 2.0 Brief Profile - Female (PROMIS SexFS) will be used to evaluate sexual activity, desire, and satisfaction among all participants.
Up to 2 years post-chemotherapy
Sexual Health
Time Frame: Up to 2 years post-chemotherapy
Sexual dysfunction will be assessed using PROMIS SexFS.
Up to 2 years post-chemotherapy
Menstrual patterns
Time Frame: Up to 2 years post-chemotherapy
Menstrual patterns will be assessed using standard items and characterized according to the Staging of Reproductive Aging Workshop criteria.
Up to 2 years post-chemotherapy
Global health-related quality of life: Sleep disturbance
Time Frame: Up to 2 years post-chemotherapy
Global health-related quality of life will be assessed using the PROMIS 29 Profile v2.1, which includes assessment of sleep disturbance. For adolescent participants, the PROMIS Pediatric Profile-25 v2.0 will be used to measure health domains, with the addition of the PROMIS Pediatric Sleep Disturbance 4a scale.
Up to 2 years post-chemotherapy
Estrogen deprivation symptoms: Headaches
Time Frame: Up to 2 years post-chemotherapy
Estrogen deprivation symptoms include headaches. The Patient-Reported Outcomes version of the Common Terminology for Adverse Events (PRO-CTCAE) will be used to collect information on the frequency and interference of headaches.
Up to 2 years post-chemotherapy
Global health-related quality of life: Anxiety
Time Frame: Up to 2 years post-chemotherapy
Global health-related quality of life will be assessed using the PROMIS 29 Profile v2.1, which includes assessment of anxiety. For adolescent participants, the PROMIS Pediatric Profile-25 v2.0 will be used to measure health domains.
Up to 2 years post-chemotherapy
Global health-related quality of life: Fatigue
Time Frame: Up to 2 years post-chemotherapy
Global health-related quality of life will be assessed using the PROMIS 29 Profile v2.1, which includes assessment of fatigue. For adolescent participants, the PROMIS Pediatric Profile-25 v2.0 will be used to measure health domains.
Up to 2 years post-chemotherapy
Global health-related quality of life: Depression
Time Frame: Up to 2 years post-chemotherapy
Global health-related quality of life will be assessed using the PROMIS 29 Profile v2.1, which includes assessment of depression. For adolescent participants, the PROMIS Pediatric Profile-25 v2.0 will be used to measure health domains.
Up to 2 years post-chemotherapy
Global health-related quality of life: Participation in social activities
Time Frame: Up to 2 years post-chemotherapy
Global health-related quality of life will be assessed using the PROMIS 29 Profile v2.1, which includes assessment of participation in social activities. For adolescent participants, the PROMIS Pediatric Profile-25 v2.0 will be used to measure health domains.
Up to 2 years post-chemotherapy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reproductive concerns
Time Frame: Up to 2 years post-chemotherapy
The reproductive concerns after cancer scale will be used for fertility potential and acceptance.
Up to 2 years post-chemotherapy
Reproductive outcomes
Time Frame: Up to 2 years post-chemotherapy
Reproductive outcomes will be assessed using selected questions from the US Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey's (NHANES) Reproductive Health module.
Up to 2 years post-chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Investigators

  • Principal Investigator: Eric J Chow, Children's Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2025

Primary Completion (Estimated)

October 30, 2029

Study Completion (Estimated)

October 30, 2029

Study Registration Dates

First Submitted

July 3, 2024

First Submitted That Met QC Criteria

July 16, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALTE2131 (Other Identifier: CTEP)
  • UG1CA189955 (U.S. NIH Grant/Contract)
  • NCI-2024-05414 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • COG-ALTE2131 (Other Identifier: DCP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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