Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00081965 |
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 Cancer-Related Problem/Condition |
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 |
Estimated Enrollment: | 80 |
OBJECTIVES:
Primary
Secondary
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.
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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
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:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Principal Investigator: | Barrie R. Cassileth, PhD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000479635, MSKCC-02108A |
Study First Received: | April 27, 2004 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00081965 |
Health Authority: | United States: Federal Government |
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 |
Signs and Symptoms Skin Diseases Hot Flashes |
Breast Neoplasms Breast Diseases Recurrence |
Neoplasms Neoplasms by Site |