Clinical trial NCT06915116: Acupuncture for People Experiencing Period Loss Due to Chemotherapy
Official title: Acupuncture for Adolescent and Young Adult Cancer Patients: (AcuAYA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cancer
Period Problem
Keywords: Acupuncture
Stage I cancer
Stage II cancer
Stage III cancer
Period Loss Due to Chemotherapy
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a two arm randomized study.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Enrollment rate
timeFrame: 1 year
measure: Acupuncture treatment adherence rate.
timeFrame: up to 16 weeks
Secondary outcomes:
measure: Menses recovery
timeFrame: 1 year
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All protocol activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jun Mao, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: