Acupuncture for People Experiencing Period Loss Due to Chemotherapy

NCT ID: NCT06915116

Last Updated: 2025-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Period Problem

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a two arm randomized study.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acupuncture group

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

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

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. 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.

Wait-list Control

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

Group Type ACTIVE_COMPARATOR

No Acupuncture

Intervention Type OTHER

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

Interventions

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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. 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.

Intervention Type PROCEDURE

No Acupuncture

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* English speaking women under the age of 40, with a history of stage I, II, or III cancer at the age of 18-39
* Premenopausal status with regular menstruation at the time of diagnosis by patient report
* Completed chemotherapy within the past year
* Report 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 following the completion of chemotherapy
* Willing to adhere to all study-related procedures, including randomization to one of the two possible arms: acupuncture and WLC

Exclusion Criteria

* Metastatic cancer (stage IV)
* Had been pregnant or lactating within 3 months prior to enrollment
* History of hysterectomy or 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jun Mao, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

Commack, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Nassau (All Protocol Activities)

Rockville Centre, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jun Mao, MD, MSCE

Role: CONTACT

646-608-8553

William Tap, MD

Role: CONTACT

646-888-4163

Facility Contacts

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Jun Mao, MD, MSCE

Role: primary

646-608-8553

Jun Mao, MD, MSCE

Role: primary

646-608-8553

Jun Mao, MD, MSCE

Role: primary

646-608-8553

Jun Mao, MD, MSCE

Role: primary

646-608-8553

Jun Mao, MD, MSCE

Role: primary

646-608-8553

Jun Mao, MD, MSCE

Role: primary

646-608-8553

William Tap, MD

Role: backup

646-888-4163

Jun Mao, MD, MSCE

Role: primary

646-608-8553

Related Links

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http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

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25-020

Identifier Type: -

Identifier Source: org_study_id

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