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

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 a...

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Autores principales: Di Meglio, Antonio, Martin, Elise, Crane, Tracy E., Charles, Cecile, Barbier, Aude, Raynard, Bruno, Mangin, Anthony, Tredan, Olivier, Bouleuc, Carole, Cottu, Paul H., Vanlemmens, Laurence, Segura-Djezzar, Carine, Lesur, Anne, Pistilli, Barbara, Joly, Florence, Ginsbourger, Thomas, Coquet, Bernadette, Pauporte, Iris, Jacob, Guillemette, Sirven, Aude, Bonastre, Julia, Ligibel, Jennifer A., Michiels, Stefan, Vaz-Luis, Ines
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8896231/
https://www.ncbi.nlm.nih.gov/pubmed/35246219
http://dx.doi.org/10.1186/s13063-022-06090-6
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author Di Meglio, Antonio
Martin, Elise
Crane, Tracy E.
Charles, Cecile
Barbier, Aude
Raynard, Bruno
Mangin, Anthony
Tredan, Olivier
Bouleuc, Carole
Cottu, Paul H.
Vanlemmens, Laurence
Segura-Djezzar, Carine
Lesur, Anne
Pistilli, Barbara
Joly, Florence
Ginsbourger, Thomas
Coquet, Bernadette
Pauporte, Iris
Jacob, Guillemette
Sirven, Aude
Bonastre, Julia
Ligibel, Jennifer A.
Michiels, Stefan
Vaz-Luis, Ines
author_facet Di Meglio, Antonio
Martin, Elise
Crane, Tracy E.
Charles, Cecile
Barbier, Aude
Raynard, Bruno
Mangin, Anthony
Tredan, Olivier
Bouleuc, Carole
Cottu, Paul H.
Vanlemmens, Laurence
Segura-Djezzar, Carine
Lesur, Anne
Pistilli, Barbara
Joly, Florence
Ginsbourger, Thomas
Coquet, Bernadette
Pauporte, Iris
Jacob, Guillemette
Sirven, Aude
Bonastre, Julia
Ligibel, Jennifer A.
Michiels, Stefan
Vaz-Luis, Ines
author_sort Di Meglio, Antonio
collection PubMed
description 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/m(2), 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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spelling pubmed-88962312022-03-10 A phase III randomized trial of weight loss to reduce cancer-related fatigue among overweight and obese breast cancer patients: MEDEA Study design Di Meglio, Antonio Martin, Elise Crane, Tracy E. Charles, Cecile Barbier, Aude Raynard, Bruno Mangin, Anthony Tredan, Olivier Bouleuc, Carole Cottu, Paul H. Vanlemmens, Laurence Segura-Djezzar, Carine Lesur, Anne Pistilli, Barbara Joly, Florence Ginsbourger, Thomas Coquet, Bernadette Pauporte, Iris Jacob, Guillemette Sirven, Aude Bonastre, Julia Ligibel, Jennifer A. Michiels, Stefan Vaz-Luis, Ines Trials Study Protocol 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/m(2), 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 BioMed Central 2022-03-04 /pmc/articles/PMC8896231/ /pubmed/35246219 http://dx.doi.org/10.1186/s13063-022-06090-6 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Di Meglio, Antonio
Martin, Elise
Crane, Tracy E.
Charles, Cecile
Barbier, Aude
Raynard, Bruno
Mangin, Anthony
Tredan, Olivier
Bouleuc, Carole
Cottu, Paul H.
Vanlemmens, Laurence
Segura-Djezzar, Carine
Lesur, Anne
Pistilli, Barbara
Joly, Florence
Ginsbourger, Thomas
Coquet, Bernadette
Pauporte, Iris
Jacob, Guillemette
Sirven, Aude
Bonastre, Julia
Ligibel, Jennifer A.
Michiels, Stefan
Vaz-Luis, Ines
A phase III randomized trial of weight loss to reduce cancer-related fatigue among overweight and obese breast cancer patients: MEDEA Study design
title A phase III randomized trial of weight loss to reduce cancer-related fatigue among overweight and obese breast cancer patients: MEDEA Study design
title_full A phase III randomized trial of weight loss to reduce cancer-related fatigue among overweight and obese breast cancer patients: MEDEA Study design
title_fullStr A phase III randomized trial of weight loss to reduce cancer-related fatigue among overweight and obese breast cancer patients: MEDEA Study design
title_full_unstemmed A phase III randomized trial of weight loss to reduce cancer-related fatigue among overweight and obese breast cancer patients: MEDEA Study design
title_short A phase III randomized trial of weight loss to reduce cancer-related fatigue among overweight and obese breast cancer patients: MEDEA Study design
title_sort phase iii randomized trial of weight loss to reduce cancer-related fatigue among overweight and obese breast cancer patients: medea study design
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8896231/
https://www.ncbi.nlm.nih.gov/pubmed/35246219
http://dx.doi.org/10.1186/s13063-022-06090-6
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