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Open Access 01-12-2022 | Obesity | Study protocol

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

Authors: Antonio Di Meglio, Elise Martin, Tracy E. Crane, Cecile Charles, Aude Barbier, Bruno Raynard, Anthony Mangin, Olivier Tredan, Carole Bouleuc, Paul H. Cottu, Laurence Vanlemmens, Carine Segura-Djezzar, Anne Lesur, Barbara Pistilli, Florence Joly, Thomas Ginsbourger, Bernadette Coquet, Iris Pauporte, Guillemette Jacob, Aude Sirven, Julia Bonastre, Jennifer A. Ligibel, Stefan Michiels, Ines Vaz-Luis

Published in: Trials | Issue 1/2022

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.gov NCT04304924

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Title: A phase III randomized trial of weight loss to reduce cancer-related fatigue among overweight and obese breast cancer patients: MEDEA Study design
Authors: Antonio Di Meglio
Elise Martin
Tracy E. Crane
Cecile Charles
Aude Barbier
Bruno Raynard
Anthony Mangin
Olivier Tredan
Carole Bouleuc
Paul H. Cottu
Laurence Vanlemmens
Carine Segura-Djezzar
Anne Lesur
Barbara Pistilli
Florence Joly
Thomas Ginsbourger
Bernadette Coquet
Iris Pauporte
Guillemette Jacob
Aude Sirven
Julia Bonastre
Jennifer A. Ligibel
Stefan Michiels
Ines Vaz-Luis
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Obesity
Obesity
Breast Cancer
Breast Cancer
Cancer Fatigue
Overweight
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06090-6

2024 ASCO Annual Meeting

Springer Medicine

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

Methods

Discussion

Trial registration

2024 ASCO Annual Meeting

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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