Acupuncture in Treating Hot Flashes in Women With Breast Cancer
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.
Procedure: acupuncture therapy
Procedure: hot flashes attenuation
Procedure: management of therapy complications
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||Acupuncture for the Treatment of Hot Flashes in Breast Cancer Patients: A Randomized Controlled Trial|
- Frequency and severity of hot flashes, as measured by a hot flash diary
|Study Completion Date:||May 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
- Determine whether acupuncture, compared to placebo, reduces the incidence of hot flashes in women with breast cancer.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00081965
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Barrie R. Cassileth, PhD||Memorial Sloan Kettering Cancer Center|