NCT06915116

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 cancer

Timeline
11mo left

Started Mar 2025

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Mar 2025Mar 2027

Study Start

First participant enrolled

March 31, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

April 1, 2025

Last Update Submit

April 13, 2026

Conditions

CancerPeriod Problem

Keywords

AcupunctureStage I cancerStage II cancerStage III cancerPeriod Loss Due to Chemotherapy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Menses recovery

    1 year

Study Arms (2)

Acupuncture group

EXPERIMENTAL

Participants in the acupuncture group will receive 12 acupuncture treatments over 12 weeks during the study.

Procedure: Acupuncture

Wait-list Control (WLC)

ACTIVE COMPARATOR

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

Interventions

No AcupunctureOTHER

Will have the option to receive the same acupuncture treatment as the acupuncture group after a 16-week waiting period

Wait-list Control (WLC)
AcupuncturePROCEDURE

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.

Acupuncture group

Eligibility Criteria

Age15 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMenses recovery
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (All Protocol Activities)

Rockville Centre, New York, 11553, United States

RECRUITING

Related Links

MeSH Terms

Conditions

NeoplasmsMenstruation Disturbances

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Jun Mao, MD, MSCE

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Mao, MD, MSCE

CONTACT

646-608-8553maoj@mskcc.org

William Tap, MD

CONTACT

646-888-4163

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a two arm randomized study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2025

First Posted

April 8, 2025

Study Start

March 31, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Locations

US(7)