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

Abstract

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. 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. 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). IER + RE improved PFS and QoL without evidence of harms warranting a further larger randomised study in ABC. https://www.isrctn.com/ISRCTN12841416 .