Acupuncture for People Experiencing Period Loss Due to Chemotherapy

Acupuncture for Adolescent and Young Adult Cancer Patients: (AcuAYA)

The purpose of this study is to find out whether it is practical (feasible) to use acupuncture to treat period loss (amenorrhea) caused by chemotherapy treatment in people with cancer. The researchers will look at how many participants enroll and complete the study. The researchers will also study how treatment with acupuncture affects the amount of time for the menstrual cycle to return and symptoms and quality of life related to amenorrhea.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Period Problem
• Intervention / Treatment: Other: No Acupuncture; Procedure: Acupuncture

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: William Tap, MD; Phone Number: 646-888-4163
• Study Contact Backup: Name: Jun Mao, MD, MSCE; Phone Number: 646-608-8553; Email: maoj@mskcc.org

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
      • Contact: Jun Mao, MD, MSCE; Phone Number: 646-608-8553
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (All Protocol Activities)
      • Contact: Jun Mao, MD, MSCE; Phone Number: 646-608-8553
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (All Protocol Activities)
      • Contact: Jun Mao, MD, MSCE; Phone Number: 646-608-8553
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
      • Contact: Jun Mao, MD, MSCE; Phone Number: 646-608-8553
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester (All Protocol Activities)
      • Contact: Jun Mao, MD, MSCE; Phone Number: 646-608-8553
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Contact: William Tap, MD; Phone Number: 646-888-4163
      • Contact: Jun Mao, MD, MSCE; Phone Number: 646-608-8553
    • Rockville Centre, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (All Protocol Activities)
      • Contact: Jun Mao, MD, MSCE; Phone Number: 646-608-8553

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• English speaking woman between the ages of 15 and 40
• History of stage I, II, or III cancer OR stage IV or unstaged hematologic malignancy (e.g. lymphoma, leukemia, myeloma) that is stable, as assessed by care team
• Premenopausal status with regular menstruation at the time of diagnosis by patient report
• Completed cytotoxic chemotherapy within the past year
• Premenopausal status with regular menstruation at the time of diagnosis by patient report for females ages 18 or older
• Report cessation of menses during or after chemotherapy and have not experienced menses recovery at the time of enrollment.
• Have reached menarche prior to therapy or during therapy for females between 15 and 17 years old
• Patient reports cessation of menses during or after chemotherapy and have not experienced menses recovery at the time of enrollment.
• Have been without menses for at least 3 months 64 following the completion of cytotoxic chemotherapy
• Willing to adhere to all study-related procedures, including randomization to one of the two possible arms: acupuncture and WLC

Exclusion Criteria:

• Had been pregnant or lactating within 3 months prior to enrollment
• History of hysterectomy or bilateral oophorectomy
• Ongoing or planned radiation or surgery within 4 months from randomization
• Use of acupuncture for menses recovery within 3 months of enrollment
• Had been or will be receiving ovarian suppression medicine, such as leuprolide (Lupron) and goserelin (Zoladex), or hormonal contraception drugs within 3 months of enrollment or during the study period

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture group; Participants in the acupuncture group will receive 12 acupuncture treatments over 12 weeks during the study.	Procedure: Acupuncture; Acupuncture will be delivered by licensed experienced acupuncturists at MSK. The intervention includes 12 treatments of acupuncture over 12 weeks (i.e. one treatment a week) with a +/- 14-day window. This window applies to the 12-week treatment period rather than to individual visits. The minimum required time between each treatment is 48 hours. When patients experience menses recovery during the treatment period, they have the option to discontinue treatment or continue receiving up to 12 acupuncture sessions for symptom management over 12 weeks.
Active Comparator: Wait-list Control (WLC); Participants in the wait-list control group will be put on a wait-list and have the option to receive the same acupuncture treatment as the acupuncture group after a 16-week waiting period. The 16-week waiting period will begin on the day that the WLC participant completes their baseline lab draw.	Other: No Acupuncture; Will have the option to receive the same acupuncture treatment as the acupuncture group after a 16-week waiting period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment rate	This is the proportion of patients who enroll in the study among those who are eligible and offered participation. Reason for not participating will be documented (e.g. time/commitment, not wanting to be randomized, does not want the study intervention).	1 year
Acupuncture treatment adherence rate.	adherence rate is the proportion of patients randomized to the Acupuncture arm who are treatment adherent, defined as completing 10 or more of the 12 acupuncture sessions.	up to 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menses recovery	Upon the return of menstruation, participants will inform to their CRCs. The CRCs will then send them the Bleeding Diary which is a link provided through REDCap to record the date and characteristics of their menses. They will be required to fill out this link daily until the menstrual cycle concludes	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Jun Mao, MD, MSCE, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: April 1, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Acupuncture; Stage III cancer; Stage I cancer; Stage II cancer; Period Loss Due to Chemotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms; Menstruation Disturbances; Therapeutics; Complementary Therapies; Acupuncture Therapy
• Other Study ID Numbers: 25-020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No