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NCT Number: NCT06915116

Acupuncture for People Experiencing Period Loss Due to Chemotherapy

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.

Recruiting

Interested in participating?

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Key information

Age range

15 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

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. 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

Other

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

Primary outcomes

  1. Enrollment rate

    Time frame: 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).

  2. Acupuncture treatment adherence rate.

    Time frame: 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 outcomes

  1. Menses recovery

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Mao, MD, MSCE

CONTACT

[email protected]

646-608-8553

William Tap, MD

CONTACT

646-888-4163

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Acupuncture for Adolescent and Young Adult Cancer Patients: (AcuAYA)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 8, 2025
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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