Status:
COMPLETED
Acupuncture in Treating Hot Flashes in Women With Breast Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Hot Flashes
Eligibility:
FEMALE
Phase:
NA
Brief Summary
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 c...
Detailed Description
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 acupunctu...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer (including in situ disease)
- Must be receiving treatment for breast cancer at Memorial Sloan Kettering Cancer Center (MSKCC) or its regional site (Commack)
- Has an average of 3 or more hot flashes a day during 1 week of baseline diary recording
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Female
- Pre- or postmenopausal
- Karnofsky performance status 70-100%
- Ambulatory
- No skin infection
- PRIOR CONCURRENT THERAPY:
- More than 3 weeks since prior and no concurrent treatment with any of the following during the 6 week evaluation period of the trial:
- Surgery
- Initiation of a new chemotherapy regimen
- Initiation of immunotherapy
- Initiation of radiotherapy
- Initiation or cessation of hormonal therapy
- More than 6 weeks since prior acupuncture treatment (6 months for acupuncture specifically for the treatment of hot flashes)
- No concurrent pharmacological treatment for hot flashes unless dose has been stable for 4 weeks
- No concurrent selective serotonin reuptake inhibitors (SSRIs) unless dose has been stable for 4 weeks
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2007
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00081965
End Date
May 1 2007
Last Update
December 13 2012
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021