Randomised controlled trial of intermittent vs continuous energy restriction during chemotherapy for early breast cancer

Michelle Harvie, Mary Pegington, Sacha J Howell, Nigel Bundred, Phil Foden, Judith Adams, Lee Graves, Alastair Greystoke, Mark P Mattson, Roy G Cutler, Julie Williamson, Karen Livingstone, Debbie McMullen, Katharine Sellers, Cheryl Lombardelli, Grace Cooper, Sarah McDiarmid, Anthony Howell

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: Excess adiposity at diagnosis and weight gain during chemotherapy is associated with tumour recurrence and chemotherapy toxicity. We assessed the efficacy of intermittent energy restriction (IER) vs continuous energy restriction (CER) for weight control and toxicity reduction during chemotherapy.

METHODS: One hundred and seventy-two women were randomised to follow IER or CER throughout adjuvant/neoadjuvant chemotherapy. Primary endpoints were weight and body fat change. Secondary endpoints included chemotherapy toxicity, cardiovascular risk markers, and correlative markers of metabolism, inflammation and oxidative stress.

RESULTS: Primary analyses showed non-significant reductions in weight (-1.1 (-2.4 to +0.2) kg, p = 0.11) and body fat (-1.0 (-2.1 to +0.1) kg, p = 0.086) in IER compared with CER. Predefined secondary analyses adjusted for body water showed significantly greater reductions in weight (-1.4 (-2.5 to -0.2) kg, p = 0.024) and body fat (-1.1 (-2.1 to -0.2) kg, p = 0.046) in IER compared with CER. Incidence of grade 3/4 toxicities were comparable overall (IER 31.0 vs CER 36.5%, p = 0.45) with a trend to fewer grade 3/4 toxicities with IER (18%) vs CER (31%) during cycles 4-6 of primarily taxane therapy (p = 0.063).

CONCLUSIONS: IER is feasible during chemotherapy. The potential efficacy for weight control and reducing toxicity needs to be tested in future larger trials.

CLINICAL TRIAL REGISTRATION: ISRCTN04156504.

Original languageEnglish
Pages (from-to)1157-1167
Number of pages11
JournalBritish Journal of Cancer
Volume126
Issue number8
Early online date15 Dec 2021
DOIs
Publication statusPublished - May 2022

Keywords

  • Breast Neoplasms/drug therapy
  • Caloric Restriction
  • Diet, Reducing
  • Female
  • Humans
  • Neoplasm Recurrence, Local
  • Obesity

Research Beacons, Institutes and Platforms

  • Manchester Cancer Research Centre

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