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Acupuncture in Treating Hot Flashes in Women With Breast Cancer

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ClinicalTrials.gov Identifier: NCT00081965
Recruitment Status : Completed
First Posted : April 28, 2004
Last Update Posted : December 13, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

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

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 Type : Interventional  (Clinical Trial)
Estimated 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
Primary Completion Date : May 2007
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
ClinicalTrials.gov Identifier: NCT00081965     History of Changes
Other Study ID Numbers: 02-108
MSKCC-02108A
First Posted: April 28, 2004    Key Record Dates
Last Update Posted: December 13, 2012
Last Verified: December 2012

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