Acupuncture in Treating Hot Flashes in Women With Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00081965|
Recruitment Status : Completed
First Posted : April 28, 2004
Last Update Posted : December 13, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Hot Flashes||Procedure: acupuncture therapy Procedure: hot flashes attenuation Procedure: management of therapy complications||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||Acupuncture for the Treatment of Hot Flashes in Breast Cancer Patients: A Randomized Controlled Trial|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||May 2007|
- Frequency and severity of hot flashes, as measured by a hot flash diary
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|