A phase III randomized trial of weight loss to reduce cancer-related fatigue among overweight and obese breast cancer patients: MEDEA Study design

Abstract

Background Elevated body mass index (BMI) represents a risk factor for cancer-related fatigue (CRF). Weight loss interventions are feasible and safe in cancer survivors, leading to improved cardio-metabolic and quality of life (QOL) outcomes and modulating inflammatory biomarkers. Randomized data are lacking showing that a lifestyle intervention aimed at weight loss, combining improved diet, exercise, and motivational counseling, reduces CRF. Motivating to Exercise and Diet, and Educating to healthy behaviors After breast cancer (MEDEA) is a multi-center, randomized controlled trial evaluating the impact of weight loss on CRF in overweight or obese survivors of breast cancer. Herein, we described the MEDEA methodology. Methods Patients (N = 220) with stage I–III breast cancer and BMI ≥ 25 kg/m2, within 12 months of primary treatment, and able to walk ≥ 400 m are eligible to enroll. Participants are randomized 1:1 to health education alone vs. a personalized telephone-based weight loss intervention plus health education. Both arms receive a health education program focusing on healthy living. Patients in the intervention arm are paired with an individual lifestyle coach, who delivers the intervention through 24 semi-structured telephone calls over 1 year. Intervention goals include weight loss ≥ 10% of baseline, caloric restriction of 500–1000 Kcal/day, and increased physical activity (PA) to 150 (initial phase) and 225–300 min/week (maintenance phase). The intervention is based on the social cognitive theory and is adapted from the Breast Cancer Weight Loss trial (BWEL, A011401). The primary endpoint is the difference in self-reported CRF (EORTC QLQ-C30) between arms. Secondary endpoints include the following: QOL (EORTC QLQ-C30, -BR45, -FA12), anxiety, and depression (HADS); weight and BMI, dietary habits and quality, PA, and sleep; health care costs (hospital-admissions, all-drug consumption, sick leaves) and cost-effectiveness (cost per quality-adjusted life-year); and patient motivation and satisfaction. The primary analysis of MEDEA will compare self-reported CRF at 12 months post-randomization between arms, with 80.0% power (two-sided α = 0.05) to detect a standardized effect size of 0.40. Discussion MEDEA will test the impact of a weight loss intervention on CRF among overweight or obese BC survivors, potentially providing additional management strategies and contributing to establish weight loss support as a new standard of clinical care. Trial registration ClinicalTrials.govNCT04304924

Dynamics of Long-Term Patient-Reported Quality of Life and Health Behaviors After Adjuvant Breast Cancer Chemotherapy

“…19 Behavioral trials of weight loss in overweight and obese BC survivors showed an impact on QOL that was particularly evident on physical function, vitality, and comorbid conditions, but most benefits tended to diminish over time, a finding that is mostly attributed to recidivism and weight regain during postintervention follow-up. [70][71][72] Ongoing randomized trials will provide additional PROs data and test whether combined interventions of weight loss (ie, with multiple components of improved diet, PA, and personalized behavioral coaching), [73][74][75] or smoking cessation programs 64,76 are able to reduce treatment-related symptoms, improve QOL, and affect clinical outcomes of BC survivors.…”

A protocol for a multidisciplinary early intervention during chemotherapy to improve dietary management behavior in breast cancer patients: a two-arm, single-center randomized controlled trial

“…However, the average daily energy intake of the BC group during chemotherapy was 214 kcal less than that of the control group. As diet is a long-term and essential lifestyle component, and changes in dietary habits caused by chemotherapy will continue to occur during recovery, advanced stages, and survival [ 47 ]. Limited studies [ 48 , 49 ] have shown that BC patients who actively manage chemotherapy-related symptoms and actively collect nutritional information may recover better and have better quality of life.…”

Association between high body mass index and prognosis of patients with early-stage breast cancer: A systematic review and meta-analysis

“…In a more recent study, Motivating to Exercise and Diet, and Educating to healthy behaviuors After breast cancer (MEDEA), which investigated the impact of weight loss on CRF in overweight or obese survivors of BC, Di Meglio et al. 73 found that an elevated BMI is a risk factor for CRF in breast cancer survivors. Thus, weight loss interventions are feasible and safe for these patients, leading to improved cardiometabolic and QOL outcomes.…”