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

Not Applicable

Active, not recruiting

• Conditions: Home Based Standardised Adapted Physical Activity Programme; Patients Taking Oral Targeted Therapy for Metastatic Cancer
• Interventions: Behavioral: Supervised physical exercise programs; Behavioral: Adapted physical activity

• Registration Number: NCT03169075
• Lead Sponsor: UNICANCER

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-05-25
• Study First Posted: 2017-05-30
• Study Start: 2017-07-11
• Primary Completion: 2024-09-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11
• Study Completion: 2028-07-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 190

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARM A: A	Supervised physical exercise programs	Supervised physical exercise programs (SPEP)
ARM B: B	Adapted physical activity	Adapted physical activity (APA)

Primary Outcome Measures

Name	Time	Method
FACT-F relative on Fatigue	Month 3 ( M3)	Self reported Questionnaires
FACT-G	Month3 ( M3)	Self Reported Questionnaire relative on Well-Being Patient

Secondary Outcome Measures

Name	Time	Method
Evaluation of Anorexia	Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year	Self reported FAACT (module A-C)
Benefit of physical activity: walk	Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year	6 minutes walking test
Physical Activity IPAQ	Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year	self reported Questionnaire IPAQ ( International Physical Activity Questionnaire)
Fatigue	Month 1, Month 2, Month 3, and every 3 months for 1 year	visual analogic scale for fatigue
Benefit of physical activity muscle function	Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year	muscle function
Quality of life	Month 1, Month 2, Month 3, and every 3 months for 1 year	Self reported Questionnaire on quality of life
Toxicities Secondaries effectsToxicities according NCI-CTC (National Cancer Institute Updates CTCAE to v.4.03. Common Terminology Criteria )	Baseline, Month 1, Month 2, Month 3, and every 3 months for 1 year	Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]).
PFS	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	Progression Free Survival
OS	From date of randomization until the date of first documented date of death from any cause, whichever came first, assessed up to 75 months	Overall Survival
Pain	Month 1, Month 2, Month 3, and every 3 months for 1 year	visual analogic scale for pain (VAS)
Physical Activity, Body Mass Index	Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year	Body Mass Index
Compliance about oral targeted therapy	Baseline, Month 1, Month 2, Month 3	Self reported Questionnaire Morisky-Green
Benefit of physical activity muscle strength	Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year	muscle strength
Scores of anxiety and depression	Baseline, Month 1, Month 2, Month 3	Hospital Anxiety and Depression Scale (HADs)
Evaluation of Ingesta, Anorexia	Baseline, Month 3	Ingesta
Evaluation of Ingesta, VAS	Baseline, Month 3	VAS
Cognitive functions	Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year	Self reported questionnaire FACT-Cog

Trial Locations

Locations (15)

CH Annecy Genevois - site d'Annecy; 🇫🇷 Annecy, France

Centre François Baclesse; 🇫🇷 Caen, France

CHD Vendée; 🇫🇷 La Roche-sur-Yon, France

CHU La Timone; 🇫🇷 Marseille, France

Centre Eugène Marquis; 🇫🇷 Rennes, France

GHMG - Institut Daniel Hollard; 🇫🇷 Grenoble, France

ICO Paul Papin; 🇫🇷 Angers, France

CH de Cholet; 🇫🇷 Cholet, France

Institut Curie Paris; 🇫🇷 Paris, France

CHRU de Besançon; 🇫🇷 Besançon, France

Hospices Civils de Lyon - Hôpital Louis Pradel; 🇫🇷 Lyon, France

CH Nimes - Institut de Cancérologie du Gard; 🇫🇷 Nîmes, France

HIA Begin; 🇫🇷 Saint-Mandé, France

INSTITUT CURIE - Site René Huguenin St Cloud; 🇫🇷 Saint-Cloud, France

ICO RenéGauducheau; 🇫🇷 Nantes, France