Acupuncture in Treating Hot Flashes in Women With Breast Cancer

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00081965

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Hot Flashes	Procedure: acupuncture therapy Procedure: hot flashes attenuation Procedure: management of therapy complications	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Primary Purpose:

Supportive Care

Official Title:

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

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

Frequency and severity of hot flashes, as measured by a hot flash diary []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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