Acupuncture in Treating Hot Flashes in Women With Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00081965
• Other study ID #: 02-108
• Secondary ID: MSKCC-02108A
• Status: Completed
• Phase: N/A
• First received: April 27, 2004
• Last updated: December 11, 2012
• Est. completion date: May 2007

Study information

• Verified date: December 2012
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Hot Flashes

Intervention

Procedure:
• acupuncture therapy

• hot flashes attenuation

• management of therapy complications

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Deng G, Vickers A, Yeung S, D'Andrea GM, Xiao H, Heerdt AS, Sugarman S, Troso-Sandoval T, Seidman AD, Hudis CA, Cassileth B. Randomized, controlled trial of acupuncture for the treatment of hot flashes in breast cancer patients. J Clin Oncol. 2007 Dec 10; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and severity of hot flashes, as measured by a hot flash diary