L-Arginine Supplements in Treating Women Who Are Cancer Survivors

September 7, 2021 updated by: Wake Forest University Health Sciences

A Randomized Study to Determine Whether ArginMax Improves the Sexual Function and Quality of Life in Female Cancer Survivors

RATIONALE: L-arginine supplements may improve the quality of life and sexual function in women who are cancer survivors.

PURPOSE: This randomized clinical trial is studying an L-arginine supplement to see how well it works compared with a placebo in treating women who are cancer survivors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine whether an L-arginine-based nutritional supplement (ArginMax®) improves the quality of life and sexual function in female cancer survivors.

Secondary

  • Compare quality of life of patients treated with ArginMax® vs placebo.
  • Compare toxicity of these regimens in these patients.
  • Describe the sexual function symptom clusters (if any) in these patients.

OUTLINE: This is a randomized, double-blind, parallel-group, placebo-controlled, multicenter study. Patients are stratified according to ECOG performance status (0 or 1 vs 2 or 3), type of malignancy (pelvic vs nonpelvic), and ovarian functional status (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive an oral L-arginine-based nutritional supplement (ArginMax®) twice daily.
  • Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 12 weeks in the absence of unacceptable toxicity.

Sexual function, quality of life, and toxicity are assessed at baseline and every 4 weeks for 12 weeks.

PROJECTED ACCRUAL: A total of 186 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

186

Phase

  • Not Applicable

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

  • United States
    • Delaware
      • Newark, Delaware, United States, 19713
        • CCOP - Christiana Care Health Services
    • Florida
      • Miami Beach, Florida, United States, 33140
        • CCOP - Mount Sinai Medical Center
    • Georgia
      • Augusta, Georgia, United States, 30912-4000
        • MBCCOP - Medical College of Georgia Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • MBCCOP - JHS Hospital of Cook County
      • Decatur, Illinois, United States, 62526
        • CCOP - Central Illinois
    • Indiana
      • South Bend, Indiana, United States, 46601
        • CCOP - Northern Indiana CR Consortium
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403-1206
        • Cedar Rapids Oncology Associates
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • MBCCOP - LSU Health Sciences Center
      • Shreveport, Louisiana, United States, 71130-3932
        • Feist-Weiller Cancer Center at Louisiana State University Health Sciences
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Royal Oak, Michigan, United States, 48073-6769
        • CCOP - Beaumont
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • CCOP - St. Louis-Cape Girardeau
      • Saint Louis, Missouri, United States, 63131
        • CCOP - Heartland Research Consortium
      • Springfield, Missouri, United States, 65804
        • CCOP - Cancer Research for the Ozarks
    • New York
      • East Syracuse, New York, United States, 13057
        • Hematology Oncology Associates of Central New York, PC - Northeast Center
      • Manhasset, New York, United States, 11030
        • CCOP - North Shore University Hospital
    • North Carolina
      • Burlington, North Carolina, United States, 27216
        • Alamance Cancer Center at Alamance Regional Medical Center
      • Elkin, North Carolina, United States, 28621
        • Hugh Chatham Memorial Hospital
      • Goldsboro, North Carolina, United States, 27534
        • Southeastern Medical Oncology Center - Goldsboro
      • Lenoir, North Carolina, United States, 28645
        • Caldwell Memorial Hospital
      • Winston-Salem, North Carolina, United States, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • Ohio
      • Columbus, Ohio, United States, 43215
        • CCOP - Columbus
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • CCOP - Main Line Health
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • CCOP - Upstate Carolina
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • CCOP - Sioux Community Cancer Consortium

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

INCLUSION CRITERIA:

Any female cancer survivor who identifies herself as concerned with her sexual quality of life and answering yes to all three of the screening questions.

  • Must express interest in sexual activity
  • At least 6 months following completion of all cancer therapy. Hormonal therapy and treatment with Herceptin are allowed.
  • No evidence of active cancer based on physical exam and/or radiographic images obtained within 3 months of study.
  • Absence of any mental, medical or physical disorder know to affect sexual function.
  • No participation in another study with an investigational study drug or device during the 30 days prior to start of study drug.
  • Lab values must meet the following criteria at study entry: WBC ≥ 2000, Hgb ≥ 10gm/dl, creatinine ≤ 1.5 x ULN, plt ≥ 100,000, T Bili ≤ 1.5
  • ECOG performance status must be 0-2.
  • Must be able to take oral medication
  • Must be 18 years old or older
  • Must be minority (non-white) female.

EXCLUSION CRITERIA:

  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to ArginMax.
  • Currently taking any blood thinner such as aspirin (one 81mg aspirin, or one baby aspirin per day allowed), Persantine, Heparin, Lovenox, or Coumadin (low dose Coumadin for catheter patency is allowed).
  • Patients currently taking Ginkgo Biloba are not allowed on this study.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac, arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements and/or ability for sexual function.
  • Pregnant women are excluded from this study because ArginMax may be an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ArginMax, breastfeeding should be discontinued if the mother is treated with ArginMax.
  • Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with ArginMax. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
  • Any planned surgery during study participation.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I: ArginMax
ArginMax® 3 pills twice daily
Dietary supplement: ArginMax
Given orally
Other Names:
  • L-arginine
Placebo Comparator: Arm II: Placebo
Patients receive oral placebo 3 pills twice daily
Dietary supplement: Placebo
Given orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual Function
Time Frame: 12 weeks
Patients filled out the Female Sexual Function Index (FSFI) at baseline and at 4, 8, and 12 weeks following randomization. The FSFI is comprised of 2 questions related to desire, 4 questions related to arousal, 4 questions related to lubrication, 3 questions related to orgasm, 3 questions related to satisfaction, and 3 questions related to pain. Subscale scores range from 1.2 to 6 (desire) or 0 to 6 (arousal, lubrication, orgasm, and pain) or 0.8 to 6 (satisfaction). A total FSFI score is computed as the sum of the individual subscales; the overall score ranges from 2 to 36. Higher scores indicate better sexual function. The primary outcome comparison is at 12 weeks.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: 12 weeks
Patients filled out the FACT-G quality of life questionnaire at baseline and at 4, 8, and 12 weeks following randomization. The FACT-G questionnaire is comprised of 7 questions related to physical well-being, 7 questions related to social well-being, 6 questions related to emotional well-being, and 7 questions related to functional well-being. Subscale scores range from 0 to 24 (Emotional) or 0 to 28 (Functional, Social, and Physical). A total FACT-G score is computed as the sum of the individual subscales; the overall score ranges from 0 to 108. Higher scores indicate better quality of life. The primary comparison was at 12 weeks.
12 weeks

Collaborators and Investigators

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

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Kathryn M. Greven, MD, Wake Forest University Health Sciences

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)

May 1, 2007

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

April 9, 2007

First Submitted That Met QC Criteria

April 9, 2007

First Posted (Estimate)

April 11, 2007

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 7, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00001487
  • U10CA081851 (U.S. NIH Grant/Contract)
  • REBACCCWFU 97106 (Other Identifier: NCI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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