Feasibility and efficacy of a supervised home-based physical exercise program for metastatic cancer patients receiving oral targeted therapy: study protocol ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2020-10-09

AUTHORS

Florence Joly, Claudia Lefeuvre-Plesse, Claire Garnier-Tixidre, Carole Helissey, Nathalie Menneveau, Alain Zannetti, Sebastien Salas, Nadine Houede, Sophie Abadie-Lacourtoisie, Laetitia Stefani, Soazig Nenan, Isabelle Rieger, Isabelle Durand-Zaleski, Jean-Marc Descotes, Amélie Anota

ABSTRACT

BackgroundCurrently, 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.MethodsQUALIOR 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.DiscussionThe 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 registrationThis trial was registered in ClinicalTrials.gov since May 2017 (NCT03169075). More... »

PAGES

975

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Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s12885-020-07381-4

DOI

http://dx.doi.org/10.1186/s12885-020-07381-4

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1131570542

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/33036567


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29 advanced cancer patients
30 advanced disease
31 aim
32 benefits
33 cancer
34 cancer patients
35 capacity
36 chemotherapy
37 cognitive function
38 compare
39 disease
40 dose reduction
41 early side effects
42 effect
43 efficacy
44 evaluation
45 exercise
46 exercise program
47 fatigue
48 feasibility
49 frequency
50 function
51 general quality
52 home-based physical exercise program
53 impact
54 life
55 medico-economic impact
56 metastatic cancer
57 metastatic cancer patients
58 months
59 multicenter
60 negative impact
61 objective
62 overall survival
63 pain
64 patients
65 patients' treatment adherence
66 phase II
67 phase II/III trials
68 phase III
69 physical activity
70 physical activity program
71 physical capacity
72 physical exercise
73 physical exercise program
74 primary objective
75 program
76 program compare
77 progression-free survival
78 protocol
79 quality
80 quality of life
81 reduction
82 secondary objective
83 side effects
84 specific physical activity programs
85 study
86 study protocol
87 supervised program
88 survival
89 targeted therapy
90 terms
91 terms of fatigue
92 therapy
93 time
94 treatment
95 treatment adherence
96 trials
97 two-part
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