Abstract
BackgroundExcess 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.MethodsOne 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.ResultsPrimary 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).ConclusionsIER is feasible during chemotherapy. The potential efficacy for weight control and reducing toxicity needs to be tested in future larger trials.Clinical trial registrationISRCTN04156504.
Highlights
Excess weight and adiposity at the time of breast cancer (BC) diagnosis and gains during treatment are linked to poorer outcomes [1]
Inclusion criteria included female sex, age ≥18 years, haemoglobin >110 g/L and body mass index (BMI) > 19 kg/m2 since the diet and physical activity (PA) plan could lead to weight loss amongst healthy weight individuals
They received 12 standard fortnightly mailings that covered aspects of their allocated diet, weight management, PA and chemotherapy (Supplementary Table 1). Both programmes used established behaviour change techniques including goal setting, self-monitoring of weight and waist, diet and PA, seeking personal support, getting back on track, vigilance for portion sizes and forming habits [17]. They both included the following safety protocols: (A) oncology teams were informed of patients with weight loss of ≥10% such that chemotherapy dose reduction could be considered if the toxicity of grade 2 or higher was experienced, (B) study dietitians advised increased energy intake if BMI reduced below 19 kg/m2 and (C) patients were advised to refrain from a moderate or vigorous activity if haemoglobin levels reduced below 90 g/L
Summary
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. 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. The potential efficacy for weight control and reducing toxicity needs to be tested in future larger trials.
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