Trial Information

The Effects of a Combined Diet and Exercise Intervention on Biomarkers Associated With Disease Recurrence After Breast Cancer Treatment: The Sheffield DEBRA Trial

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 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.

Secondary

- 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.