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

Autor: Sophie Abadie-Lacourtoisie, Isabelle Durand-Zaleski, Jean-Marc Descotes, C. Lefeuvre-Plesse, Nadine Houede, Nathalie Menneveau, Amélie Anota, Claire Garnier-Tixidre, Carole Helissey, Laetitia Stefani, Soazig Nenan, Florence Joly, Isabelle Rieger, Alain Zannetti, Sébastien Salas
Přispěvatelé: Hôpital Côte de Nacre [CHU Caen], CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU), Centre Eugène Marquis (CRLCC), Institut Daniel Hollard [Grenoble], HIA Bégin, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Centre Hospitalier de Cholet (CHC), Hôpital de la Timone [CHU - APHM] (TIMONE), Institut de Cancérologie du GARD ICG - CHU Nîmes (Instit Cancéro - GARD), Département d'oncologie médicale [Saint Herblain] (Centre René Gauducheau - ICO), Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), UNICANCER-UNICANCER, CH Annecy Genevois, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Centre de Diagnostic et de Thérapeutique, Hôpital de l’Hôtel-Dieu [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CAMI Sport et Cancer
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Quality of life
Male
Cancer Research
medicine.medical_specialty
Colorectal cancer
Medico-economy
medicine.medical_treatment
Pain
Administration
Oral
Physical exercise
[SDV.CAN]Life Sciences [q-bio]/Cancer
lcsh:RC254-282
Targeted therapy
03 medical and health sciences
Study Protocol
0302 clinical medicine
Breast cancer
Internal medicine
Genetics
medicine
Humans
030212 general & internal medicine
Oral targeted therapy
Neoplasm Metastasis
Lung cancer
Fatigue
business.industry
Cancer
Adherence to treatment
medicine.disease
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Supervised physical exercise programs
3. Good health
Exercise Therapy
Oncology
030220 oncology & carcinogenesis
Feasibility Studies
Psychological and cognitive functions
Female
business
Kidney cancer
Metastatic cancer
Supportive care
Zdroj: BMC Cancer
BMC Cancer, BioMed Central, 2020, 20 (1), ⟨10.1186/s12885-020-07381-4⟩
BMC Cancer, Vol 20, Iss 1, Pp 1-11 (2020)
ISSN: 1471-2407
DOI: 10.1186/s12885-020-07381-4⟩
Popis: 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).
Databáze: OpenAIRE
Externí odkaz: