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