Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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. 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.


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: - 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


NCT ID:

NCT00081965


Primary Contact:

Principal Investigator
Barrie R. Cassileth, PhD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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