NCT00081965

Acupuncture in Treating Hot Flashes in Women With Breast Cancer

Acupuncture for the Treatment of Hot Flashes in Breast Cancer Patients: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Hot Flashes

Interventions

Type	Name	Description
PROCEDURE	acupuncture therapy
PROCEDURE	hot flashes attenuation
PROCEDURE	management of therapy complications

Timeline

• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2004-04-28
• Last updated: 2012-12-13

Locations

1 site across 1 country: United States