Acupuncture for People Experiencing Period Loss Due to Chemotherapy

Phase 2

Recruiting

• Conditions: Cancer; Period Problem

• Registration Number: NCT06915116
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-31
• Status Verified: 2025-04
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Enrollment rate	1 year	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).
Acupuncture treatment adherence rate.	up to 16 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Menses recovery	1 year	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

Trial Locations

Locations (7)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All protocol activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (All Protocol Activities); 🇺🇸 Rockville Centre, New York, United States