Acupuncture for People Experiencing Period Loss Due to Chemotherapy

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 2

Conditions: Period Problem; Cancer

Treatments: Procedure: Acupuncture; Other: No Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06915116

25-020

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Acupuncture group

Experimental group

Description:

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

Treatment:

Procedure: Acupuncture

Wait-list Control

Active Comparator group

Description:

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

Treatment:

Other: No Acupuncture