Using acupuncture to help women regain their menstrual cycle after chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 meets at least one of the following:
* Reports cessation of menses during or after chemotherapy and have not experienced menses recovery at the time of enrollment and has been without menses for at least 3 months 64 following the completion of cytotoxic chemotherapy; OR
* Is receiving ovarian suppression therapy (e.g., leuprolide \[Lupron\] or goserelin \[Zoladex\]) or hormonal contraceptive drugs, regardless of menstrual status, and report persistent (≥3 months), moderate-to- severe menopause-related symptoms, defined as a score of ≥4 on a 0-10 scale for at least one MENQOL item during eligibility screening.
* 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 it's running

• 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)
  East White Plains, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activities)
  New York, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.