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

  • STATUS
    Recruiting
  • End date
    Jul 11, 2028
  • participants needed
    312
  • sponsor
    UNICANCER
Updated on 31 January 2022

Summary

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.

Details
Condition Home Based Standardised Adapted Physical Activity Programme, Patients Taking Oral Targeted Therapy for Metastatic Cancer
Treatment adapted physical activity, SSPA, PA, PA, Supervised physical exercise programs
Clinical Study IdentifierNCT03169075
SponsorUNICANCER
Last Modified on31 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient's 18 years old
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)
Patients starting first-line oral targeted therapy, with market authorisation. The targeted therapy may be associated with hormonal therapy
Patients may have been treated with immunotherapy
Patients may have received chemotherapy (2 lines) for their metastatic disease
Life expectancy of 3 months
ECOG performance status 2
Patients able to comply with the constraints of the SPEP protocol
Pain under control (VAS 3; 0-10 scale)
Haemoglobin level 9 g/dL
Patient must have signed the informed consent form before any study-related procedures
Patients must have public health insurance coverage

Exclusion Criteria

Patient receiving an injectable targeted therapy
Patient previously treated by more than 2 lines of treatment (previous treatment with cytokines are allowed)
Patient to be treated with chemotherapy associated with the oral targeted therapy (hormonal therapy is allowed)
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)
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)
Patient treated with corticotherapy (1 month) before randomisation at a dose 1 mg/kg
Bone metastases with risk of fractures
Geographical, sociological, or psychological reasons that could potentially hampering compliance with the study protocol and follow-up schedule
Patients with a history of non-compliance to medical treatment, reluctance or incapable to conform to the study protocol
Persons deprived of liberty or under guardianship
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