Recruiting
Phase 2

Acupuncture

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06915116

Conditions

Cancer

Period Problem

Eligibility Criteria

Sex: Female

Age: 15 - 40

Healthy Volunteers: Not accepted

Interventions

Acupuncture

No Acupuncture

Study Details

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.

Conditions

Cancer

Period Problem

Study ID

NCT06915116

Start date

Mar 31, 2025

Status verified date

Aug, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 15 - 40

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acupuncture group

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

active comparator: Wait-list Control (WLC)

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.

Interventions

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. 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.

No Acupuncture

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

Primary outcome measure

  • Enrollment rate [ Time Frame: 1 year ]
  • Acupuncture treatment adherence rate. [ Time Frame: up to 16 weeks ]

Central Contacts and Locations

Central contacts

Jun Mao, MD, MSCE

646-608-8553maoj@mskcc.org

William Tap, MD

646-888-4163

Locations

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Jun Mao, MD, MSCE

646-608-8553

Memorial Sloan Kettering Monmouth (All protocol activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Jun Mao, MD, MSCE

646-608-8553

Memorial Sloan Kettering Bergen (All Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Jun Mao, MD, MSCE

646-608-8553

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Jun Mao, MD, MSCE

646-608-8553

Memorial Sloan Kettering Westchester (All Protocol Activities)

Recruiting

East White Plains, New York, United States, 10604

Contacts

Jun Mao, MD, MSCE

646-608-8553

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Jun Mao, MD, MSCE

646-608-8553

William Tap, MD

646-888-4163

Memorial Sloan Kettering Nassau (All Protocol Activities)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Jun Mao, MD, MSCE

646-608-8553

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • Acupuncture
  • Stage I cancer
  • Stage II cancer
  • Stage III cancer
  • Period Loss Due to Chemotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-08-17.