Clinical trial NCT03169075: QUALIOR Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Home Based Standardised Adapted Physical Activity Programme
Patients Taking Oral Targeted Therapy for Metastatic Cancer
Keywords: Adapted physical activity
Oral targeted therapy
Advanced cancer
Fatigue
Quality of life
Randomized Study
Lead sponsor: UNICANCER
Sponsor class: OTHER
Collaborators: name: CAMI: Sport & Cancer
First posted: 2017-05-30
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: FACT-F relative on Fatigue
timeFrame: Month 3 ( M3)
measure: FACT-G
timeFrame: Month3 ( M3)
Secondary outcomes:
measure: PFS
timeFrame: 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
measure: OS
timeFrame: From date of randomization until the date of first documented date of death from any cause, whichever came first, assessed up to 75 months
measure: Quality of life
timeFrame: Month 1, Month 2, Month 3, and every 3 months for 1 year
measure: Fatigue
timeFrame: Month 1, Month 2, Month 3, and every 3 months for 1 year
measure: Fatigue
timeFrame: Month 1, Month 2, Month 3, and every 3 months for 1 year
measure: Pain
timeFrame: Month 1, Month 2, Month 3, and every 3 months for 1 year
measure: Toxicities Secondaries effectsToxicities according NCI-CTC (National Cancer Institute Updates CTCAE to v.4.03. Common Terminology Criteria )
timeFrame: Baseline, Month 1, Month 2, Month 3, and every 3 months for 1 year
measure: Compliance about oral targeted therapy
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Benefit of physical activity: walk
timeFrame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
measure: Benefit of physical activity muscle function
timeFrame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
measure: Benefit of physical activity muscle strength
timeFrame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
measure: Physical Activity IPAQ
timeFrame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
measure: Physical Activity, Body Mass Index
timeFrame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
measure: Scores of anxiety and depression
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Cognitive functions
timeFrame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
measure: Evaluation of Ingesta, Anorexia
timeFrame: Baseline, Month 3
measure: Evaluation of Ingesta, VAS
timeFrame: Baseline, Month 3
measure: Evaluation of Anorexia
timeFrame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Other outcomes:
Locations:
city: Angers
country: France
facility: ICO Paul Papin
city: Annecy
country: France
facility: CH Annecy Genevois - site d'Annecy
city: Besançon
country: France
facility: CHRU de Besançon
city: Caen
country: France
facility: Centre François Baclesse
city: Cholet
country: France
facility: CH de Cholet
city: Grenoble
country: France
facility: GHMG - Institut Daniel Hollard
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hôpital Louis Pradel
city: Marseille
country: France
facility: CHU La Timone
city: Nantes
country: France
facility: ICO RenéGauducheau
city: Nîmes
country: France
facility: CH Nimes - Institut de Cancérologie du Gard
city: Paris
country: France
facility: Institut Curie Paris
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Saint-Cloud
country: France
facility: INSTITUT CURIE - Site René Huguenin St Cloud
city: Saint-Mandé
country: France
facility: HIA Begin
Study officials:
affiliation: Centre François Baclesse
name: Florence JOLY, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joly F, Lefeuvre-Plesse C, Garnier-Tixidre C, Helissey C, Menneveau N, Zannetti A, Salas S, Houede N, Abadie-Lacourtoisie S, Stefani L, Nenan S, Rieger I, Durand-Zaleski I, Descotes JM, Anota A. Feasibility and efficacy of a supervised home-based physical exercise program for metastatic cancer patients receiving oral targeted therapy: study protocol for the phase II/III - UNICANCER SdS 01 QUALIOR trial. BMC Cancer. 2020 Oct 9;20(1):975. doi: 10.1186/s12885-020-07381-4.