Informations générales (source: ClinicalTrials.gov)
Study Evaluating the Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program, for Metastatic Cancer Patients Receiving Oral Targeted Therapy: The UNICANCER SdS 01 QUALIOR Study (QUALIOR)
Interventional
N/A
UNICANCER (Voir sur ClinicalTrials)
juillet 2017
juillet 2028
14 novembre 2024
This phase II-III study will be randomized (2:1) patients starting first-line oral
targeted therapies (OTT) for metastatic cancer between an individualized supervised
physical exercise programs (SPEP) by a personal coach, and recommended physical exercises
via a booklet. Eligible patients will have received ≤2 lines of metastatic chemotherapy,
Eastern Cooperative Oncology Group Performance status (ECOG PS) ≤2, controlled pain
(visual analogue scale (VAS) <3/10), and life expectancy ≥3 months.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | Contact (sur clinicalTrials) | ||||
| CLCC RENE HUGUENIN INSTITUT CURIE | Contact (sur clinicalTrials) | ||||
| HIA BEGIN | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Eugène Marquis - 35042 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Centre François Baclesse - 14076 - Caen - France | Contact (sur clinicalTrials) | ||||
| CH Annecy Genevois - site d'Annecy - 74474 - Annecy - France | Contact (sur clinicalTrials) | ||||
| CH de Cholet - 49300 - Cholet - France | Contact (sur clinicalTrials) | ||||
| CHRU de Besançon - 25000 - Besançon - France | Contact (sur clinicalTrials) | ||||
| Hospices Civils de Lyon - Hôpital Louis Pradel - 69000 - Lyon - France | Contact (sur clinicalTrials) | ||||
| ICO Paul Papin - 49000 - Angers - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH Nimes - Institut de Cancérologie du Gard - 30000 - Nîmes - France | Contact (sur clinicalTrials) | ||||
| CHD Vendée - 85925 - La Roche-sur-Yon - France | Contact (sur clinicalTrials) | ||||
| CHU La Timone - 13000 - Marseille - France | Contact (sur clinicalTrials) | ||||
| GHMG - Institut Daniel Hollard - MD Phd - Grenoble - France | Contact (sur clinicalTrials) | ||||
| ICO RenéGauducheau - 44000 - Nantes - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Patient's ≥18 years old.
2. Patient treated for a metastatic solid tumour within the following 4 cohorts: breast
cancer, kidney cancer, lung cancer, and other tumours treated with oral targeted
therapies (including melanomas, sarcomas, hepatic sarcomas, and colon cancers).
3. Patients starting first-line oral targeted therapy, with market authorisation. The
targeted therapy may be associated with hormonal therapy.
4. Patients may have been treated with immunotherapy.
5. Patients may have received chemotherapy (≤2 lines) for their metastatic disease.
6. Life expectancy of ≥3 months.
7. ECOG performance status ≤2.
8. Patients able to comply with the constraints of the SPEP protocol.
9. Pain under control (VAS ˂3; 0-10 scale).
10. Haemoglobin level ≥9 g/dL.
11. Patient must have signed the informed consent form before any study-related
procedures.
12. Patients must have public health insurance coverage.
1. Patient's ≥18 years old.
2. Patient treated for a metastatic solid tumour within the following 4 cohorts: breast
cancer, kidney cancer, lung cancer, and other tumours treated with oral targeted
therapies (including melanomas, sarcomas, hepatic sarcomas, and colon cancers).
3. Patients starting first-line oral targeted therapy, with market authorisation. The
targeted therapy may be associated with hormonal therapy.
4. Patients may have been treated with immunotherapy.
5. Patients may have received chemotherapy (≤2 lines) for their metastatic disease.
6. Life expectancy of ≥3 months.
7. ECOG performance status ≤2.
8. Patients able to comply with the constraints of the SPEP protocol.
9. Pain under control (VAS ˂3; 0-10 scale).
10. Haemoglobin level ≥9 g/dL.
11. Patient must have signed the informed consent form before any study-related
procedures.
12. Patients must have public health insurance coverage.
1. Patient receiving an injectable targeted therapy.
2. Patient previously treated by more than 2 lines of treatment (previous treatment
with cytokines are allowed)
3. Patient to be treated with chemotherapy associated with the oral targeted therapy
(hormonal therapy is allowed).
4. Patient with known risk of fracture, symptomatic cardiac insufficiency (NYHA-3),
respiratory insufficiency (grade 3), intense pain not controlled with analgesic
treatment, and/or neuropathy (grade 3).
5. Patients with a history of cancer in the last 5 years (except basal cell carcinoma
adequately treated and in situ cervical cancer treated and cured).
6. Patient treated with corticotherapy (˃1 month) before randomisation at a dose ˃1
mg/kg.
7. Bone metastases with risk of fractures.
8. Geographical, sociological, or psychological reasons that could potentially
hampering compliance with the study protocol and follow-up schedule.
9. Patients with a history of non-compliance to medical treatment, reluctance or
incapable to conform to the study protocol.
10. Persons deprived of liberty or under guardianship.