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Acupuncture for the Treatment of Hot Flashes in Breast Cancer Patients: A Randomized Controlled Trial
RATIONALE: Acupuncture may help relieve hot flashes in women with breast cancer. It is not yet known whether acupuncture is more effective than a placebo in treating hot flashes in women with breast cancer PURPOSE: This randomized clinical trial is studying acupuncture to see how well it works compared to a placebo in treating hot flashes in women with breast cancer.
OBJECTIVES: Primary * Determine whether acupuncture, compared to placebo, reduces the incidence of hot flashes in women with breast cancer. Secondary * Determine the long-term effects of acupuncture on hot flashes. OUTLINE: This a randomized, placebo-controlled, multicenter study. Patients are stratified according to concurrent treatment with selective estrogen receptor modulators, gonadotropin-releasing hormone analogs, or aromatase inhibitors (yes vs no), concurrent use of hot flash medication or selective serotonin reuptake inhibitors (SSRIs) (yes vs no), baseline hot flash frequency (\> 7 per day), and menopausal status at diagnosis (premenopausal vs postmenopausal). Patients are randomized to 1 of 2 treatment arms. * Arm I (treatment): Patients receive 8 acupuncture treatments over 4 weeks. * Arm II (control): Patients receive 8 placebo acupuncture treatments over 4 weeks. Beginning at week 7, patients are offered 8 true acupuncture treatments over 4 weeks. Patients in both arms complete a "hot flash" diary for 1 week before treatment and then periodically during and after treatment. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Age
All ages
Sex
FEMALE
Healthy Volunteers
No
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Primary Completion Date
May 1, 2007
Completion Date
May 1, 2007
Last Updated
December 13, 2012
80
ESTIMATED participants
acupuncture therapy
PROCEDURE
hot flashes attenuation
PROCEDURE
management of therapy complications
PROCEDURE
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
NCT04704661
NCT05245812
Data Source & Attribution
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