Status:
COMPLETED
Diet and Exercise or Normal Care in Overweight or Obese Women Who Have Undergone Treatment for Stage I, Stage II, or Stage III Breast Cancer
Lead Sponsor:
Sheffield Hallam University
Conditions:
Breast Cancer
Eligibility:
FEMALE
Phase:
NA
Brief Summary
RATIONALE: Studying diet and exercise interventions in overweight and obese patients with breast cancer may help doctors learn more about how to help patients lose weight and change their body composi...
Detailed Description
OBJECTIVES: Primary * To examine the effects of a dietary and exercise intervention on body weight and body composition in overweight or obese women who have undergone breast cancer treatment. * To ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of stage I, II, or III breast cancer
- No metastatic breast cancer
- No inoperable or active loco-regional disease
- Body mass index (BMI) \> 25
- Patients must have completed treatment for breast cancer within the past 3-18 months
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- Willing and able to attend supervised exercise sessions at least 3 times per week for a period of 24 weeks
- Patients must be an exercise pre-contemplator, contemplator, or preparer as defined by the transtheoretical model
- No physical/psychiatric impairment that would seriously impair physical mobility
- No severe nausea, anorexia, or other diseases affecting health (e.g., arthritis and multiple sclerosis)
- More than 3 months since prior exercise and not currently engaged in exercise (two or more times per week for at least 30 minutes per session)
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Concurrent tamoxifen, other endocrine treatments, and trastuzumab (Herceptin®) allowed
- No concurrent alternative/complementary diets
- No concurrent high-dose antioxidant supplement therapy
- More than 4 months since prior and no concurrent hormone-replacement therapy or oral contraceptives
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00689975
Start Date
February 1 2006
Last Update
August 26 2013
Active Locations (1)
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1
Sheffield Hallam University - City Campus
Sheffield, England, United Kingdom, S1O 2JF