Using acupuncture to help women regain their menstrual cycle after chemotherapy
Acupuncture for Adolescent and Young Adult Cancer Patients: (AcuAYA)
This study is testing if acupuncture can help women under 40 who lost their periods after chemotherapy get their menstrual cycles back.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 15 Years to 40 Years |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT06915116 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of acupuncture as a treatment for period loss (amenorrhea) in women under 40 who have undergone chemotherapy for stage I, II, or III cancer. Researchers will assess participant enrollment and completion rates, as well as the impact of acupuncture on the return of menstrual cycles and related quality of life issues. Participants will be randomly assigned to receive either acupuncture or no acupuncture treatment. The study will focus on women who have not had their menstrual cycle for at least three months following chemotherapy.
Who should consider this trial
Good fit: Ideal candidates are English-speaking women under 40 who have completed chemotherapy for stage I, II, or III cancer and have experienced period loss for at least three months.
Not a fit: Patients with metastatic cancer, those who have undergone hysterectomy or oophorectomy, or those currently receiving ovarian suppression treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive treatment option to help restore menstrual cycles in women affected by chemotherapy.
How similar studies have performed: While acupuncture has been explored in various contexts, this specific application for period loss due to chemotherapy is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (All protocol activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (All Protocol Activities) — Rockville Centre, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jun Mao, MD, MSCE — Memorial Sloan Kettering Cancer Center
- Study coordinator: Jun Mao, MD, MSCE
- Email: maoj@mskcc.org
- Phone: 646-608-8553
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.