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Acupuncture in Treating Hot Flashes in Women With Breast Cancer
This study is ongoing, but not recruiting participants.
Study NCT00081965   Information provided by National Cancer Institute (NCI)
First Received: April 27, 2004   Last Updated: May 9, 2009   History of Changes

April 27, 2004
May 9, 2009
 
 
Frequency and severity of hot flashes, as measured by a hot flash diary
Same as current
Complete list of historical versions of study NCT00081965 on ClinicalTrials.gov Archive Site
 
 
 
Acupuncture in Treating Hot Flashes in Women With Breast Cancer
Acupuncture for the Treatment of Hot Flashes in Breast Cancer Patients: A Randomized Controlled Trial

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.

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.

 
Interventional
Supportive Care, Randomized, Placebo Control
  • Breast Cancer
  • Hot Flashes
  • Procedure: acupuncture therapy
  • Procedure: hot flashes attenuation
  • Procedure: management of therapy complications
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
80
 
 

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
Female
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00081965
 
CDR0000479635, MSKCC-02108A
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Barrie R. Cassileth, PhD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP