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Randomised phase-2 screening trial of intermittent energy restriction plus resistance exercise versus resistance exercise alone during chemotherapy for advanced breast cancer

Harvie, M.
; 
Pegington, M.
; 
Howell, A.
; 
Lim, Y.
; 
Livingstone, K.
; 
Rose, D.
; 
McMullan, D.
; 
Maxwell, A.
; 
Barrett, E.
; 
Sellers, K.
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Abstract
BACKGROUND: Weight control and energy restriction could improve survival in patients with advanced breast cancer (ABC) but randomised data are lacking. A randomised screening trial was conducted to assess an intermittent energy restricted diet and resistance exercise intervention (IER + RE) vs RE alone (RE) on progression free survival (PFS), toxicity and Quality of Life (QoL) during chemotherapy for ABC. METHODS: Sixty-eight women were randomised to IER + RE (n = 35) or RE (n = 33) with one-sided significance assessed at the 20% threshold. The primary end point was PFS secondary endpoints included chemotherapy toxicity, weight change and QoL. RESULTS: The adjusted hazard rate for progression comparing IER + RE vs RE was 0.729 (0.391-1.361) and the median PFS 42.0 vs 26.1 weeks respectively (p = 0.160). Toxicity was low and comparable between groups. Comparing IER + RE vs RE alone at cycle 3 the median (interquartile range) changes were: weight -1.8 kg (-4.2 to -0.7) vs +0.2 kg (-0.74, 2.59) (p < 0.001), FACT-B + 4.0 (-0.8, 11) vs +1.0 (-4.0, 4.0) (p = 0.031) and Hospital Anxiety Depression Score -2.0 (-3.5, +0.5) vs +1.0 (-2, 3.5) (p = 0.022). CONCLUSION: IER + RE improved PFS and QoL without evidence of harms warranting a further larger randomised study in ABC. TRIAL REGISTRATION: https://www.isrctn.com/ISRCTN12841416 .
Authors
Harvie, M.
Pegington, M.
Howell, A.
Lim, Y.
Livingstone, K.
Rose, D.
McMullan, D.
Maxwell, A.
Barrett, E.
Sellers, K.
Krizak, S.
Howell, S. J.
Affiliation
Nightingale/Prevent Breast Cancer Centre, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, M23 9LT, UK. michelle.harvie@manchester.ac.uk. Division of Cancer Sciences, The University of Manchester, Manchester, UK. michelle.harvie@manchester.ac.uk. Manchester Breast Centre, Oglesby Cancer Research Centre, The Christie NHS Foundation Trust, University of Manchester, Manchester, UK. michelle.harvie@manchester.ac.uk. Nightingale/Prevent Breast Cancer Centre, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, M23 9LT, UK. Division of Cancer Sciences, The University of Manchester, Manchester, UK. Manchester Breast Centre, Oglesby Cancer Research Centre, The Christie NHS Foundation Trust, University of Manchester, Manchester, UK. Research and Innovation, Manchester University Hospital Foundation NHS Trust, Manchester, UK. Centre for Biostatistics, The University of Manchester, Manchester, UK. Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.
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2025
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Harvie M, Pegington M, Howell A, Lim Y, Livingstone K, Rose D, et al. Randomised phase-2 screening trial of intermittent energy restriction plus resistance exercise versus resistance exercise alone during chemotherapy for advanced breast cancer. British journal of cancer. 2025 Oct;133(7):1010-9. PubMed PMID: 40745221. Pubmed Central PMCID: PMC12479916 to follow intermittent diets. All author proceeds are paid directly to the charity Prevent Breast Cancer (Registered Charity Number 1109839) to fund breast cancer research. Ethics approval and consent to participate: This study was reviewed by the NRES Committee Northwest—Greater Manchester West, reference 14/NW/1396. Written informed consent was obtained from all participants and the study was performed in accordance with the Declaration of Helsinki. Epub 2025/08/01. eng.
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https://christie.openrepository.com/handle/10541/628043
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