A phase III randomized trial of weight loss to reduce cancer-related fatigue among overweight and obese breast cancer patients: MEDEA Study design.
Body mass index
Breast cancer
Cancer-related fatigue
Obesity
Overweight
Survivorship
Weight loss
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
04 Mar 2022
04 Mar 2022
Historique:
received:
20
11
2020
accepted:
07
02
2022
entrez:
5
3
2022
pubmed:
6
3
2022
medline:
9
3
2022
Statut:
epublish
Résumé
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. Patients (N = 220) with stage I-III breast cancer and BMI ≥ 25 kg/m 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. ClinicalTrials.gov NCT04304924.
Sections du résumé
BACKGROUND
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
METHODS
Patients (N = 220) with stage I-III breast cancer and BMI ≥ 25 kg/m
DISCUSSION
CONCLUSIONS
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
BACKGROUND
ClinicalTrials.gov NCT04304924.
Identifiants
pubmed: 35246219
doi: 10.1186/s13063-022-06090-6
pii: 10.1186/s13063-022-06090-6
pmc: PMC8896231
doi:
Banques de données
ClinicalTrials.gov
['NCT04304924']
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
193Subventions
Organisme : Institut National du Cancer
ID : RISP 2018-13684
Organisme : Susan G. Komen
ID : CCR17483507
Pays : United States
Organisme : Conquer Cancer Foundation
ID : Career Pathway Grant in Symptom Management
Informations de copyright
© 2022. The Author(s).
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