Efficacy of Acupuncture for Hot Flashes in Women Treated With Hormonal Therapy for Breast Cancer
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy of Acupuncture for Hot Flashes in Women Treated With Hormonal Therapy for Breast Cancer|
- Define efficacy of acupuncture to points of the enhanced Ming Men technique for relief of hot flashes after hormonal therapy for breast cancer. [ Time Frame: weekly evaluation up to 9 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||July 2003|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Sham Comparator: Sham acupuncture therapy
Sham acupuncture therapy
Procedure: Sham acupuncture therapy
Sham procedure will be insertion of 5 needles for 20 minutes provided twice during first week, then once per week thereafter.
Active Comparator: Acupuncture
Acupuncture using enhanced Ming Men technique for 20 minutes, twice during 1st week, then once during week 2, 3,and 4.
No Intervention: Observation
The purpose of this study is to determine if acupuncture is effective in relieving hot flashes in women treated with hormonal therapy for breast cancer.
Hormonal therapy is one of the most common treatments for breast cancer in women. Unfortunately, many women on hormonal therapy suffer from hot flashes (the sudden sensation of heat throughout the face, neck and chest, with or without shivering and sweating). Many medicines have been used to treat hot flashes, but no single medication has been found to work reliably.
Acupuncture has been shown to be effective for many conditions in Western medicine specifically for dry mouth in people who have received radiation to their head and neck, as well as for hot flashes in women during menopause (the "change of life"). In this study, we are investigating whether acupuncture is effective for women suffering hot flashes that result from their treatment of breast cancer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209001
|United States, Georgia|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Peter Johnstone, MD||Emory University Winship Cancer Institute|