Acupuncture in Treating Hot Flashes in Women With Breast Cancer
NCT ID: NCT00081965
Last Updated: 2012-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2007-05-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
Interventions
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acupuncture therapy
hot flashes attenuation
management of therapy complications
Eligibility Criteria
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Inclusion Criteria
* 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
Sponsors
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National Cancer Institute (NCI)
NIH
Memorial Sloan Kettering Cancer Center
OTHER
Principal Investigators
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Barrie R. Cassileth, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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References
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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;25(35):5584-90. doi: 10.1200/JCO.2007.12.0774.
Other Identifiers
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MSKCC-02108A
Identifier Type: -
Identifier Source: secondary_id
02-108
Identifier Type: -
Identifier Source: org_study_id