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.Results Summary
Background Being a health weight and having lower calorie intakes could improve survival amongst advanced cancer patients with overweight or obesity, but there is little evidence of this. We undertook a trial to assess whether an intermittent energy restricted diet and resistance exercise intervention compared to resistance exercise alone can impact on the time that chemotherapy keeps working in patients with advanced breast cancer. Also, whether the diet helps reduce some of the side effects of drugs and improve wellbeing. The trial was designed to show if the diet had sufficient promising evidence, it may be beneficial but was not big enough to provide definite proof.
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Methods
Sixty-eight women were randomly allocated to receive either an intermittent energy restricted diet and resistance exercise intervention or resistance exercise alone. The main outcome of interest was the length of time the chemotherapy kept working before there was progression of the cancer. We also looked at the number and severity of chemotherapy side effects and the wellbeing of the patients Results The patients who received the diet and exercise programme had 42 weeks on chemotherapy before their cancers progressed while the exercise only group had 26 weakish suggesting t a survival advantage in the group undertaking the intermittent diet. There were few chemotherapy side effects in both groups and these were comparable . The intermittent diet lost on average 1.8 kg of weight whilst the exercise only group gained 0.2 kg. The intermittent diet had better improvements in a well-being score and lower scores on an anxiety and depression score Conclusion The intermittent diet and resistance exercise programme may help improve the length of time chemotherapy works for women with metastatic breast cancer and may help improve well-being. There was no evidence of harms with the diet. This study suggests a further larger trial of the diet in the population to provide definite evidence of the effects of the diet.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