Acupuncture in Treating Hot Flashes in Women With Breast Cancer - Full Text View

Sponsor:	Memorial Sloan-Kettering Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00081965

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.

Condition	Intervention
Breast Cancer Hot Flashes	Procedure: acupuncture therapy Procedure: hot flashes attenuation Procedure: management of therapy complications

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Placebo Control
Official Title:	Acupuncture for the Treatment of Hot Flashes in Breast Cancer Patients: A Randomized Controlled Trial

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Acupuncture Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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

Estimated Enrollment:

80

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081965

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Barrie R. Cassileth, PhD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Deng G, Vickers A, Yeung S, Cassileth B. Randomized, controlled trial of acupuncture for the treatment of hot flashes in breast cancer patients. J Clin Oncol. 2007 Dec 10;25(35):5584-90.

Study ID Numbers:	CDR0000479635, MSKCC-02108A
Study First Received:	April 27, 2004
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00081965 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Signs and Symptoms
Neoplasms
Neoplasms by Site
Skin Diseases

Hot Flashes
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 25, 2009