B-AHEAD 3; Breast - Activity and Healthy Eating After Diagnosis - 3
Research type
Research Study
Full title
B-AHEAD 3 ; Breast - Activity and Healthy Eating After Diagnosis - 3 A randomised phase II trial of intermittent energy restriction and resistance exercise in women receiving chemotherapy for advanced breast cancer.
IRAS ID
165097
Contact name
Michelle Harvie
Contact email
Duration of Study in the UK
2 years, 6 months, days
Research summary
Many metastatic breast cancer patients are above an ideal weight with high body fat and low muscle stores. Many patients gain fat and lose muscle during chemotherapy, and too much fat and low muscle stores can make chemotherapy less effective and increase its side effects.
This randomised trial will test the potential beneficial effects of a calorie restricted diet and resistance exercise compared to a resistance exercise programme on disease progression amongst 134 metastatic breast cancer patients scheduled to receive paclitaxel or capecitabine chemotherapy.
Patients will be recruited from 11 breast cancer treatment centres in the Manchester, Cheshire area.
Half of the women will be asked to follow a diet and exercise programme which includes a 5:2 calorie restricted diet and resistance (strength) training 3 times per week
Half of the women will be asked to do resistance (strength) training 3 times per week. Both groups will be asked to follow these programmes during their current course of chemotherapy (median period 5.4 months).
We will examine the difference between the two groups on:
Time to disease progression, chemotherapy toxicity, quality of life, fatigue, change in weight, waist circumference, fat and muscle mass which we can assess from their routine treatment CT scan.
This is a randomised phase II screening trial. If the results from this diet and exercise weight loss intervention are positive we will look to perform a national phase III study.REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
14/NW/1396
Date of REC Opinion
10 Dec 2014
REC opinion
Further Information Favourable Opinion