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
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 composition.
PURPOSE: This randomized clinical trial is studying diet and exercise to see how well it works compared with normal care in overweight or obese women who have undergone treatment for stage I, stage II, or stage III breast cancer.
Behavioral: behavioral dietary intervention
Behavioral: exercise intervention
Other: counseling intervention
Other: flow cytometry
Other: immunoenzyme technique
Other: laboratory biomarker analysis
Procedure: complementary or alternative medicine procedure
Procedure: standard follow-up care
|Study Design:||Allocation: Randomized|
|Official Title:||The Effects of a Combined Diet and Exercise Intervention on Biomarkers Associated With Disease Recurrence After Breast Cancer Treatment: The Sheffield DEBRA Trial|
- Body weight [ Designated as safety issue: No ]
- Body composition [ Designated as safety issue: No ]
- Pychological stress via the Perceived Stress Scale [ Designated as safety issue: No ]
- Depression via the Beck Depression Inventory II [ Designated as safety issue: No ]
- Cardiorespiratory fitness [ Designated as safety issue: No ]
- Quality of life via the FACT-G and FACT-B [ Designated as safety issue: No ]
|Study Start Date:||February 2006|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
- 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 examine the effects of a dietary and exercise intervention on indices of psychological health status and biomarkers associated with disease recurrence in overweight or obese women who have undergone breast cancer treatment.
- To examine the relationship between change in body weight and biomarkers associated with disease recurrence and physiological health status, including circulating levels of estrogen, C-reactive protein, and interleukin-6.
- To examine the relationship between changes in psychological health status, circulating stress hormones, and indices of immune function.
- To examine the effects of the dietary and exercise intervention on broader quality-of-life dimensions.
OUTLINE: Patients are randomized to one of intervention arms.
- Arm I (lifestyle intervention): Patients undergo moderate-intensity aerobic-exercise sessions 3 to 5 days a week for 24 weeks. Patients not able to attend five supervised sessions are counseled on how they can fit an extra 1-2 home/community-based exercise sessions into their weekly routine. All sessions of physical activity are recorded in a physical activity log. Portable pedometers are used to determine the number of steps/distance walked each day. Patients wear heart-rate monitors throughout the exercise sessions. Heart rate and ratings of perceived exertion are assessed at regular intervals. The exercise-therapy sessions use a variety of cognitive-behavioral techniques for promoting exercise adherence as well as positive attitudes and experiences.
Patients are also given individualized healthy-eating dietary advice and written information packet named ' Weight Loss On A Plate'. Patients are also counseled on how to reduce their dietary fat intake to 25% of total caloric intake, eating at least 5 portions of fruit and vegetables daily, increasing fiber intake, reducing carbohydrates, and taking moderate amounts of alcohol. Patients are also counseled on how to reduce their total daily calorie intake to 600 kcal below their calculated energy requirements. Individual energy requirements will be estimated from a formula of basal metabolic rate and physical activity level. Patients complete a 3-day diet diary prior to beginning study treatment and then weekly throughout the study. The diaries from pre-intervention and from weeks 6, 12, 18, and 24 are analyzed, looking specifically at macronutrients. Patients meet with the research assistant once weekly to discuss their individual diet diaries and identify ways in which they can further improve their nutritional intake.
- Arm II (normal care): Patients are provided with a general healthy-eating booklet entitled, "Getting the Balance Right".
Depression, psychological stress, and quality of life are assessed at baseline and then at 12 weeks, and 25 weeks.
Blood samples are examined for various biomarkers including interleukin-6 by ELISA, estradiol by radioimmunoassay, and for lymphocyte phenotyping and NK-cell activity by flow cytometry.
Salivary cortisol levels are measured 4 times on two consecutive days by high-sensitivity salivary cortisol enzyme immunoassay.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00689975
|Sheffield Hallam University - City Campus|
|Sheffield, England, United Kingdom, S1O 2JF|
|Principal Investigator:||John M. Saxton, PhD||Royal Hallamshire Hospital|