Status:
COMPLETED
Effect of a Low-Calorie Diet and/or Exercise Program on Risk Factors for Developing Breast Cancer in Overweight or Obese Postmenopausal Women
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Obesity
Eligibility:
FEMALE
50-75 years
Phase:
NA
Brief Summary
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/...
Detailed Description
OBJECTIVES: Primary * Compare the effects of a 1-year exercise intervention, reduced-calorie diet intervention, or a combined exercise and reduced-calorie diet intervention vs no intervention on ser...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- At increased risk for developing breast cancer due to any of the following lifestyle risk factors:
- Lack of physical activity
- Excess weight
- Obesity
- Weight gain over lifetime
- Body mass index \> 25.0
- Physically able to undertake a moderate exercise or calorie reduction program
- No history of invasive or in situ breast cancer
- PATIENT CHARACTERISTICS:
- Postmenopausal, defined by the absence of periods for the past 12 months
- Able to attend study clinic visits and classes, and undergo study measurements
- Able to fill out questionnaires and logs in English
- No moderate to high alcohol intake (more than 2 drinks per day)
- No concurrent smoking
- No invasive cancer within the past 10 years except simple basal cell or squamous cell carcinoma
- No diabetes mellitus
- Fasting blood sugar \< 126 mg/dL (on 2 occasions)
- Hematocrit 32-48%
- WBC 3,000-15,000/mm³
- Potassium 3.5-5.0 mEq/L
- Creatinine ≤ 2.0 mg/dL
- No abnormalities on screening physical that contraindicate study participation
- No contraindications for treadmill testing or entry into a training program, including any of the following:
- Myocardial infarction within the past 6 months
- Pulmonary edema
- Myocarditis
- Pericarditis
- Unstable angina
- Pulmonary embolism or deep vein thrombosis
- Uncontrolled hypertension (i.e., blood pressure \> 200/100 mm Hg)
- Orthostatic hypotension
- Moderate-to-severe aortic stenosis
- Uncontrolled arrhythmia
- Uncontrolled congestive heart failure
- Third-degree heart block
- Left bundle branch block
- Thrombophlebitis
- ST depression \> 3 mm at rest
- History of cardiac arrest or stroke
- Normal exercise treadmill testing (ETT)
- Negative thallium or echo ETT required for patients with abnormal ETT (defined as ≥ 1.5 mm ST depression in \> 1 lead within 1-minute recovery OR ≥ 1.1 mm ST depression in \> 1 lead after 1-minute recovery OR reading of positive test by study doctor)
- No drug abuse
- No significant mental illness
- PRIOR CONCURRENT THERAPY:
- More than 6 months since prior and no concurrent menopausal hormone replacement therapy of any type, including vaginal route
- No concurrent participation in any other organized weight loss or exercise program
- No concurrent appetite suppressant medication
- No concurrent medications (e.g., weight-loss medications) likely to interfere with adherence to interventions or study outcomes
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
439 Patients enrolled
Trial Details
Trial ID
NCT00470119
Start Date
December 1 2004
End Date
February 1 2010
Last Update
September 10 2012
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024