QUALIOR Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program

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

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.

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.

Exclusion Criteria:

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.