The purpose of this trial is to determine whether acupuncture reduces the incidence of hot flashes in women with breast cancer.

Condition	Treatment or Intervention	Phase
Breast Neoplasms Hot Flashes	Procedure: Acupuncture	Phase III

Hot flashes are a common side effect of treatment for breast and prostate cancer. Opioids produced by the body are associated with these hot flashes. Acupuncture causes a release of endorphins that may affect opioid levels. Several studies have shown significant decreases in hot flashes following acupuncture treatment. This study will expose participants to either acupuncture or placebo to determine the effectiveness of acupuncture in alleviating hot flashes in breast cancer patients.

Participants in this study will be randomly assigned to receive eight sessions of either real or placebo acupuncture over 4 weeks. Participants will monitor their hot flashes in a diary that will be analyzed 6, 13, and 26 weeks after the start of the study. The frequency and severity of hot flashes will be measured. At the end of 4 weeks, participants in the placebo group will be offered real acupuncture.

Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Treatment for breast cancer
• Average of three or more hot flashes a day
• Ability to walk

Exclusion Criteria:

• Surgery; initiation of a new chemotherapy regimen, immunotherapy, or radiotherapy; or initiation or cessation of hormonal therapy during the study or for 3 weeks before the start of the study
• Pharmacological treatment of hot flashes or use of selective serotonin reuptake inhibitors (unless the dose has been stable for 4 weeks)
• Skin infections
• Any acupuncture treatment within the 6 weeks prior to study entry or acupuncture given specifically for the treatment of hot flashes within 6 months prior to study entry

Terri S. Gray, MS      212-639-3305    grayt@mskcc.org
Barrie R. Cassileth, PhD      212-639-8629 

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting

Study ID Numbers:  1-R21-CA098565-01
Record last reviewed:  September 2004
Record first received:  April 27, 2004
ClinicalTrials.gov Identifier:  NCT00081965
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-05