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Acupuncture for the Treatment of Period Loss Due to Chemotherapy in Adolescent and Young Adult Cancer Patients
Trial Status: active
This clinical trial tests how well acupuncture works in treating period loss (amenorrhea) due to chemotherapy in adolescent and young adult (AYA) cancer patients. Acupuncture is a technique of inserting thin needles through the skin at specific points on the body to control pain and other symptoms. It is a type of complementary and alternative medicine. Studies in animals and people without cancer have shown that acupuncture may help recover function of the ovaries and balance sex hormone levels which are important for regular period (menstrual) cycles. In people with cancer, acupuncture has also been shown to reduce symptoms such as insomnia, hot flashes, pain, fatigue, and anxiety. However, currently, there is no effective treatment option for period loss caused by chemotherapy in people with cancer. Giving acupuncture treatment may shorten the amount of time for the menstrual cycle to return and improve symptoms and quality of life related to amenorrhea in AYA cancer patients.
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 wait-list control (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
Additional locations may be listed on ClinicalTrials.gov for NCT06915116.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Jun J. Mao
Phone: 646-608-8553
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Jun J. Mao
Phone: 646-608-8553
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Jun J. Mao
Phone: 646-608-8553
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Jun J. Mao
Phone: 646-608-8553
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Jun J. Mao
Phone: 646-608-8553
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Jun J. Mao
Phone: 646-608-8553
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Jun J. Mao
Phone: 646-608-8553
PRIMARY OBJECTIVE:
I. To assess the feasibility of acupuncture for chemotherapy-related amenorrhea (CRA) in AYA patients.
SECONDARY OBJECTIVE:
I. To evaluate the preliminary effects of acupuncture on time to menses recovery and menopause-related symptoms and menopause-related quality of life in AYA patients.
EXPLORATORY OBJECTIVE:
I. To evaluate the preliminary effects of acupuncture on sex hormone biomarkers (follicle-stimulating hormone [FSH], estradiol [E2], and anti-Müllerian hormone [AMH]) in AYA patients.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (ACUPUNCTURE): Patients undergo acupuncture treatment sessions over 30-45 minutes once weekly (QW) for up to 12 weeks.
ARM II (WAIT-LIST): Patients complete study assessments at baseline and at 12 weeks. After week 16, patients may undergo 12 sessions of acupuncture treatment.
After completion of study treatment, patients are followed up in 4 weeks.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
