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Background <p>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.</p> Methods <p>Sixty-eight women were randomised to IER + RE (<i>n</i> = 35) or RE (<i>n</i> = 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.</p> Results <p>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 (<i>p</i> = 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) (<i>p</i> &lt; 0.001), FACT-B + 4.0 (–0.8, 11) vs +1.0 (–4.0, 4.0) (<i>p</i> = 0.031) and Hospital Anxiety Depression Score –2.0 (–3.5, +0.5) vs +1.0 (–2, 3.5) (<i>p</i> = 0.022).</p> Conclusion <p>IER + RE improved PFS and QoL without evidence of harms warranting a further larger randomised study in ABC.</p> Trial registration <p><a href="https://www.isrctn.com/ISRCTN12841416">https://www.isrctn.com/ISRCTN12841416</a>.</p>

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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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月31日

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  • Michelle Harvie,
  • Mary Pegington,
  • Anthony Howell,
  • Yit Lim,
  • Karen Livingstone,
  • Danielle Rose,
  • Debbie McMullan,
  • Anthony Maxwell,
  • Emma Barrett,
  • Katharine Sellers,
  • Suzanne Krizak,
  • Sacha J. Howell

摘要

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.