NCT00081965CompletedNot Applicable
Acupuncture for the Treatment of Hot Flashes in Breast Cancer Patients: A Randomized Controlled Trial
Memorial Sloan Kettering Cancer Center1 site in 1 country80 target enrollmentStarted: April 28, 2004Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Frequency and severity of hot flashes, as measured by a hot flash diary
Study Overview
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 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.
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 acupuncture on hot flashes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Supportive Care
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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:
- •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:
- •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 Criteria
- Not provided
Outcomes
Primary Outcomes
Frequency and severity of hot flashes, as measured by a hot flash diary
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Treatment of Hot Flushes in Breast Cancer Patients With AcupuncturePostmenopauseBreast CancerNCT00425776Vejle Hospital94
Terminated
Not Applicable
Efficacy of Acupuncture for Hot Flashes in Women Treated With Hormonal Therapy for Breast CancerBreast CancerNCT00209001Emory University7
Completed
Phase 3
Acupuncture or Self-Acupuncture in Managing Cancer-Related Fatigue in Women Who Have Received Chemotherapy for Stage I, Stage II, or Stage IIIA Breast CancerBreast CancerFatigueAnxiety DisorderDepressionNCT00957112University of Manchester320
Terminated
Phase 2
Acupuncture or Medication in Reducing Pain in Postmenopausal Women With Breast Cancer and Joint PainMenopausal SymptomsPainBreast CancerNCT00892268University of Arizona68
Terminated
Not Applicable
Acupuncture in Treating Hot Flashes in Patients With Prostate CancerFatigueHot FlashesProstate CancerNCT00244894OHSU Knight Cancer Institute22