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| Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00470119 |
Purpose
RATIONALE: A low-calorie diet and/or exercise program may help lower an overweight or obese postmenopausal woman's risk of developing breast cancer. It is not yet known whether a low-calorie diet and/or exercise program are more effective than no diet or exercise program in lowering an overweight or obese postmenopausal woman's risk of developing breast cancer.
PURPOSE: This randomized clinical trial is studying the effect of a low-calorie diet and/or exercise program on risk factors for developing breast cancer compared with no diet or exercise program in overweight or obese postmenopausal women.
| Condition | Intervention |
|
Breast Cancer Obesity Weight Changes |
Procedure: behavioral dietary intervention Procedure: complementary or alternative medicine procedure Procedure: dietary intervention Procedure: educational intervention Procedure: evaluation of cancer risk factors Procedure: exercise intervention Procedure: immunoscintigraphy Procedure: laboratory biomarker analysis Procedure: mammography Procedure: preventative dietary intervention Procedure: quality-of-life assessment |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer Exercise and Physical Fitness Mammography Obesity |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized |
| Official Title: | Exercise Diet and Sex Hormones in Postmenopausal Women (NEW) |
| Estimated Enrollment: | 503 |
| Study Start Date: | December 2004 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 50 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At increased risk for developing breast cancer due to any of the following lifestyle risk factors:
PATIENT CHARACTERISTICS:
No diabetes mellitus
No contraindications for treadmill testing or entry into a training program, including any of the following:
Normal exercise treadmill testing (ETT)
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Washington | |||||
| Fred Hutchinson Cancer Research Center | Recruiting | ||||
| Seattle, Washington, United States, 98109-1024 | |||||
| Contact: Anne McTiernan, MD 206-667-7979 | |||||
| Fred Hutchinson Cancer Research Center |
| National Cancer Institute (NCI) |
| Principal Investigator: | Anne McTiernan, MD | Fred Hutchinson Cancer Research Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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| Study ID Numbers: | CDR0000544634, FHCRC-PHS-1960.00, FHCRC-1960 |
| First Received: | May 3, 2007 |
| Last Updated: | July 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00470119 |
| Health Authority: | Unspecified |
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