Breast Cancer, Hot Flashes
Conditions
Keywords
breast cancer in situ, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IV breast cancer, recurrent breast cancer, stage IIIC breast cancer, hot flashes
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. 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.
Interventions
PROCEDUREacupuncture therapy
PROCEDUREhot flashes attenuation
PROCEDUREmanagement of therapy complications
Sponsors
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Primary purpose
SUPPORTIVE_CARE
Eligibility
Sex/Gender
FEMALE
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: * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and severity of hot flashes, as measured by a hot flash diary | — |
Countries
United States
Outcome results
None listed