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Feasibility and efficacy of a supervised home-based physical exercise program for metastatic cancer patients receiving oral targeted therapy: study protocol for the phase II/III - UNICANCER SdS 01 QUALIOR trial

BACKGROUND: Currently, oral targeted therapies are known to be effective and are frequently used to treat metastatic cancer patients, but fatigue is a frequently reported early side effect of these treatments. This fatigue may impact the patient’s treatment adherence and result in a negative impact...

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Autores principales: Joly, Florence, Lefeuvre-Plesse, Claudia, Garnier-Tixidre, Claire, Helissey, Carole, Menneveau, Nathalie, Zannetti, Alain, Salas, Sebastien, Houede, Nadine, Abadie-Lacourtoisie, Sophie, Stefani, Laetitia, Nenan, Soazig, Rieger, Isabelle, Durand-Zaleski, Isabelle, Descotes, Jean-Marc, Anota, Amélie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7545839/
https://www.ncbi.nlm.nih.gov/pubmed/33036567
http://dx.doi.org/10.1186/s12885-020-07381-4
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author Joly, Florence
Lefeuvre-Plesse, Claudia
Garnier-Tixidre, Claire
Helissey, Carole
Menneveau, Nathalie
Zannetti, Alain
Salas, Sebastien
Houede, Nadine
Abadie-Lacourtoisie, Sophie
Stefani, Laetitia
Nenan, Soazig
Rieger, Isabelle
Durand-Zaleski, Isabelle
Descotes, Jean-Marc
Anota, Amélie
author_facet Joly, Florence
Lefeuvre-Plesse, Claudia
Garnier-Tixidre, Claire
Helissey, Carole
Menneveau, Nathalie
Zannetti, Alain
Salas, Sebastien
Houede, Nadine
Abadie-Lacourtoisie, Sophie
Stefani, Laetitia
Nenan, Soazig
Rieger, Isabelle
Durand-Zaleski, Isabelle
Descotes, Jean-Marc
Anota, Amélie
author_sort Joly, Florence
collection PubMed
description BACKGROUND: Currently, oral targeted therapies are known to be effective and are frequently used to treat metastatic cancer patients, but fatigue is a frequently reported early side effect of these treatments. This fatigue may impact the patient’s treatment adherence and result in a negative impact on quality of life. Physical exercise significantly improved the general well-being and quality of life of advanced cancer patients. However, there is no specific physical activity program adapted for patients with advanced disease. METHODS: QUALIOR is a two-part, randomized, open-label, and multicenter with two arms phase II/III trial. Patients (phase II: n = 120; phase III: n = 312) with metastatic cancer (breast cancer, kidney cancer, lung cancer, and other cancers [including but not limited to colon cancer, melanoma, sarcoma, or hepatocarcinoma]) treated with a first- or second-line oral targeted therapy without chemotherapy will be included. Patients will be randomized (2:1) to a 3-month supervised home-based standardized physical activity program or to a recommended adapted physical activity (via a booklet). The primary objective of the phase II is to evaluate the feasibility of the supervised program. The primary objective of the phase III is the evaluation of the benefit of the supervised home-based program compare to the recommended program in terms of fatigue and quality of life at 3 months. The secondary objectives aim to evaluate the impact of the supervised program on fatigue over time, pain, physical capacities, psychosocial and cognitive functions, general quality of life, frequency of dose reduction and patients’ adherence to the targeted therapy, overall survival, and progression-free survival. This study will also evaluate the medico-economic impact of supervised program compared to the recommended adapted physical activity program. DISCUSSION: The aim of this study is to evaluate home-based physical exercise program for metastatic cancer patients treated with oral targeted therapies to help patients to cope with fatigue and improve quality of life. TRIAL REGISTRATION: This trial was registered in ClinicalTrials.gov since May 2017 (NCT03169075).
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spelling pubmed-75458392020-10-13 Feasibility and efficacy of a supervised home-based physical exercise program for metastatic cancer patients receiving oral targeted therapy: study protocol for the phase II/III - UNICANCER SdS 01 QUALIOR trial Joly, Florence Lefeuvre-Plesse, Claudia Garnier-Tixidre, Claire Helissey, Carole Menneveau, Nathalie Zannetti, Alain Salas, Sebastien Houede, Nadine Abadie-Lacourtoisie, Sophie Stefani, Laetitia Nenan, Soazig Rieger, Isabelle Durand-Zaleski, Isabelle Descotes, Jean-Marc Anota, Amélie BMC Cancer Study Protocol BACKGROUND: Currently, oral targeted therapies are known to be effective and are frequently used to treat metastatic cancer patients, but fatigue is a frequently reported early side effect of these treatments. This fatigue may impact the patient’s treatment adherence and result in a negative impact on quality of life. Physical exercise significantly improved the general well-being and quality of life of advanced cancer patients. However, there is no specific physical activity program adapted for patients with advanced disease. METHODS: QUALIOR is a two-part, randomized, open-label, and multicenter with two arms phase II/III trial. Patients (phase II: n = 120; phase III: n = 312) with metastatic cancer (breast cancer, kidney cancer, lung cancer, and other cancers [including but not limited to colon cancer, melanoma, sarcoma, or hepatocarcinoma]) treated with a first- or second-line oral targeted therapy without chemotherapy will be included. Patients will be randomized (2:1) to a 3-month supervised home-based standardized physical activity program or to a recommended adapted physical activity (via a booklet). The primary objective of the phase II is to evaluate the feasibility of the supervised program. The primary objective of the phase III is the evaluation of the benefit of the supervised home-based program compare to the recommended program in terms of fatigue and quality of life at 3 months. The secondary objectives aim to evaluate the impact of the supervised program on fatigue over time, pain, physical capacities, psychosocial and cognitive functions, general quality of life, frequency of dose reduction and patients’ adherence to the targeted therapy, overall survival, and progression-free survival. This study will also evaluate the medico-economic impact of supervised program compared to the recommended adapted physical activity program. DISCUSSION: The aim of this study is to evaluate home-based physical exercise program for metastatic cancer patients treated with oral targeted therapies to help patients to cope with fatigue and improve quality of life. TRIAL REGISTRATION: This trial was registered in ClinicalTrials.gov since May 2017 (NCT03169075). BioMed Central 2020-10-09 /pmc/articles/PMC7545839/ /pubmed/33036567 http://dx.doi.org/10.1186/s12885-020-07381-4 Text en © The Author(s) 2020 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/. The Creative Commons Public Domain Dedication waiver (http://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
Joly, Florence
Lefeuvre-Plesse, Claudia
Garnier-Tixidre, Claire
Helissey, Carole
Menneveau, Nathalie
Zannetti, Alain
Salas, Sebastien
Houede, Nadine
Abadie-Lacourtoisie, Sophie
Stefani, Laetitia
Nenan, Soazig
Rieger, Isabelle
Durand-Zaleski, Isabelle
Descotes, Jean-Marc
Anota, Amélie
Feasibility and efficacy of a supervised home-based physical exercise program for metastatic cancer patients receiving oral targeted therapy: study protocol for the phase II/III - UNICANCER SdS 01 QUALIOR trial
title Feasibility and efficacy of a supervised home-based physical exercise program for metastatic cancer patients receiving oral targeted therapy: study protocol for the phase II/III - UNICANCER SdS 01 QUALIOR trial
title_full Feasibility and efficacy of a supervised home-based physical exercise program for metastatic cancer patients receiving oral targeted therapy: study protocol for the phase II/III - UNICANCER SdS 01 QUALIOR trial
title_fullStr Feasibility and efficacy of a supervised home-based physical exercise program for metastatic cancer patients receiving oral targeted therapy: study protocol for the phase II/III - UNICANCER SdS 01 QUALIOR trial
title_full_unstemmed Feasibility and efficacy of a supervised home-based physical exercise program for metastatic cancer patients receiving oral targeted therapy: study protocol for the phase II/III - UNICANCER SdS 01 QUALIOR trial
title_short Feasibility and efficacy of a supervised home-based physical exercise program for metastatic cancer patients receiving oral targeted therapy: study protocol for the phase II/III - UNICANCER SdS 01 QUALIOR trial
title_sort feasibility and efficacy of a supervised home-based physical exercise program for metastatic cancer patients receiving oral targeted therapy: study protocol for the phase ii/iii - unicancer sds 01 qualior trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7545839/
https://www.ncbi.nlm.nih.gov/pubmed/33036567
http://dx.doi.org/10.1186/s12885-020-07381-4
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