Trial Information

B- AHEAD Study (Breast - Activity & Healthy Eating After Diagnosis) Randomised Comparison of 3 Weight Control Programmes During Adjuvant Treatment for Early Breast Cancer.

OBJECTIVES:

Primary

- To assess changes in body weight and composition (i.e., body fat, fat-free mass, dual
energy x-ray absorptiometry, bioelectrical impedance, and waist and hip circumference)
in patients with early stage breast cancer.

Secondary

- To assess uptake and retention to the interventions and adverse effects of the
interventions in these patients.

OUTLINE: This is a multicenter study.

Patients are stratified according to adjuvant treatment (chemotherapy vs no chemotherapy),
body mass index (> 27kg/m² vs < 27 kg/m²), treating hospital (UHSM vs North Manchester vs
Royal Oldham vs Stepping Hill Hospital), high vs low risk of reducing bone density (i.e.,
patients receiving aromatase inhibitors vs premenopausal women receiving chemotherapy and/or
tamoxifen vs postmenopausal women receiving tamoxifen), and high vs low risk of developing
lymphedema (i.e., axillary node clearance vs no axillary node clearance). Patients are
randomized to 1 of 3 interventions.

- Arm I: Patients receive standard written advice "Healthy Living With Breast Cancer"
booklet from South Manchester University Hospital.

- Arm II: Patients receive individualized diet and exercise advice from a study dietitian
for 40 minutes and from the exercise referral officer for 40 minutes. Advice is
reinforced with 20-minute bi-weekly phone calls checking compliance, changes in diet,
physical activity, individual problems and goals, and recommendations. Patients also
receive mailed information summarizing key motivational, behavioral, diet, and exercise
issues; information covered in group sessions on weight management; and a booklet
providing a program of walking, strengthening, toning, and flexibility exercises.

- Arm III: Patients undergo a supervised group community weight control intervention
based on Courneya's exercise prescription guidelines for breast cancer patients and
survivors. The intervention consists of a 5-minute warm-up comprising walking and
movement to music, 20-30 minutes of circuit training with approximately 10 stations
incorporating aerobic activities (i.e., brisk walking, cycling, low-level exercise to
music) and muscle strengthening activities (i.e., wall press-up, side leg raises, light
weights, and resistance bands), 10-minute cool-down with stretch and flexibility
exercises, and 5-minute relaxation period. Patients also undergo a 30-minute diet and
behavior change educational session based on the trans theoretical model of behavior
changes. The intervention repeats once weekly for 12 weeks. Patients receive a booklet
providing a program of walking, strengthening, toning, and flexibility exercises.
Patients also receive booster phone calls to reinforce advice, problem solve, and
monitor compliance at 4, 6, and 9 months.

In all arms, quality of life is assessed at baseline and 3, 6, and 12 months. Serum bone
markers, insulin, glucose, and cardiovascular disease markers are measured periodically.