Home Based Standardised Adapted Physical Activity Programme Clinical Trial
— QUALIOROfficial title:
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
| Verified date | November 2023 |
| Source | UNICANCER |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 190 |
| Est. completion date | July 11, 2028 |
| Est. primary completion date | October 11, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | ICO Paul Papin | Angers | |
| France | CH Annecy Genevois - site d'Annecy | Annecy | |
| France | CHRU de Besançon | Besançon | |
| France | Centre François Baclesse | Caen | |
| France | CH de Cholet | Cholet | |
| France | GHMG - Institut Daniel Hollard | Grenoble | |
| France | CHD Vendée | La Roche-sur-Yon | |
| France | Hospices Civils de Lyon - Hôpital Louis Pradel | Lyon | |
| France | CHU La Timone | Marseille | |
| France | ICO RenéGauducheau | Nantes | |
| France | CH Nimes - Institut de Cancérologie du Gard | Nîmes | |
| France | Institut Curie Paris | Paris | |
| France | Centre Eugène Marquis | Rennes | |
| France | INSTITUT CURIE - Site René Huguenin St Cloud | Saint-Cloud | |
| France | HIA Begin | Saint-Mandé |
| Lead Sponsor | Collaborator |
|---|---|
| UNICANCER | CAMI: Sport & Cancer |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | FACT-F relative on Fatigue | Self reported Questionnaires | Month 3 ( M3) | |
| Primary | FACT-G | Self Reported Questionnaire relative on Well-Being Patient | Month3 ( M3) | |
| Secondary | PFS | Progression Free Survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 75 months | |
| Secondary | OS | Overall Survival | From date of randomization until the date of first documented date of death from any cause, whichever came first, assessed up to 75 months | |
| Secondary | Quality of life | Self reported Questionnaire on quality of life | Month 1, Month 2, Month 3, and every 3 months for 1 year | |
| Secondary | Fatigue | Self reported Questionnaire FACT-F on Fatigue | Month 1, Month 2, Month 3, and every 3 months for 1 year | |
| Secondary | Fatigue | visual analogic scale for fatigue | Month 1, Month 2, Month 3, and every 3 months for 1 year | |
| Secondary | Pain | visual analogic scale for pain (VAS) | Month 1, Month 2, Month 3, and every 3 months for 1 year | |
| Secondary | Toxicities Secondaries effectsToxicities according NCI-CTC (National Cancer Institute Updates CTCAE to v.4.03. Common Terminology Criteria ) | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). | Baseline, Month 1, Month 2, Month 3, and every 3 months for 1 year | |
| Secondary | Compliance about oral targeted therapy | Self reported Questionnaire Morisky-Green | Baseline, Month 1, Month 2, Month 3 | |
| Secondary | Benefit of physical activity: walk | 6 minutes walking test | Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year | |
| Secondary | Benefit of physical activity muscle function | muscle function | Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year | |
| Secondary | Benefit of physical activity muscle strength | muscle strength | Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year | |
| Secondary | Physical Activity IPAQ | self reported Questionnaire IPAQ ( International Physical Activity Questionnaire) | Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year | |
| Secondary | Physical Activity, Body Mass Index | Body Mass Index | Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year | |
| Secondary | Scores of anxiety and depression | Hospital Anxiety and Depression Scale (HADs) | Baseline, Month 1, Month 2, Month 3 | |
| Secondary | Cognitive functions | Self reported questionnaire FACT-Cog | Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year | |
| Secondary | Evaluation of Ingesta, Anorexia | Ingesta | Baseline, Month 3 | |
| Secondary | Evaluation of Ingesta, VAS | VAS | Baseline, Month 3 | |
| Secondary | Evaluation of Anorexia | Self reported FAACT (module A-C) | Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year |