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Acupuncture in Treating Hot Flashes in Women With Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00081965
First received: April 27, 2004
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  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: Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: Acupuncture for the Treatment of Hot Flashes in Breast Cancer Patients: A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Frequency and severity of hot flashes, as measured by a hot flash diary

Estimated Enrollment: 80
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
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:

ClinicalTrials.gov Identifier: NCT00081965     History of Changes
Other Study ID Numbers: 02-108, MSKCC-02108A
Study First Received: April 27, 2004
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
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:
Breast Neoplasms
Hot Flashes
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013