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

NCT03169075 | Active Not Recruiting

• 1 other identifier: UC-0106/1510 SdS 01 QUALIOR
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 15

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.

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

Outcome Measures

Primary Outcomes (2)

• FACT-F relative on Fatigue

  Self reported Questionnaires

  Month 3 ( M3)

• FACT-G

  Self Reported Questionnaire relative on Well-Being Patient

  Month3 ( M3)

Secondary Outcomes (18)

• 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

• 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

• Quality of life

  Month 1, Month 2, Month 3, and every 3 months for 1 year

• Fatigue

  Month 1, Month 2, Month 3, and every 3 months for 1 year

• Fatigue

  Month 1, Month 2, Month 3, and every 3 months for 1 year

Study Arms (2)

ARM A: A

EXPERIMENTAL

Supervised physical exercise programs (SPEP)

Behavioral: Supervised physical exercise programs

ARM B: B

ACTIVE COMPARATOR

Adapted physical activity (APA)

Behavioral: Adapted physical activity

Interventions

Supervised physical exercise programs BEHAVIORAL

A weekly supervised physical activity session of 60 min at the patient's home is planned for 3 months. These sessions will be supervised by an educator or physiotherapist trained, with respect to the pathology and the clinical study, specifically for this activity (Fédération Française Sport et Cancer) . The proposed exercises will be normalized and adapted to each patient's profile. Self reported questionnaires: FACT-F, FACT-G, EQ-5D, FAACT module AC/S, FACT-Gog, HADS, IPAQ, Evaluation by a coach VAE

ARM A: A

Adapted physical activity BEHAVIORAL

Program based on the recommendations for performing a physical activity. A booklet containing physical activity recommendations will be given to the patients after randomization. The weekly sessions at the patients home for the experimental group (Program A) must begin as soon as possible within the 15 days after starting oral targeted therapy. Self reported questionnaires: FACT-F, FACT-G, EQ-5D, FAACT module AC/S, FACT-Gog, HADS, IPAQ

ARM B: B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNICANCER: lead
• CAMI: Sport & Cancer: collaborator

Study Sites (15)

ICO Paul Papin

Angers, 49000, France

Location

CH Annecy Genevois - site d'Annecy

Annecy, 74474, France

Location

CHRU de Besançon

Besançon, 25000, France

Location

Centre François Baclesse

Caen, 14076, France

Location

CH de Cholet

Cholet, 49300, France

Location

GHMG - Institut Daniel Hollard

Grenoble, MD Phd, France

Location

CHD Vendée

La Roche-sur-Yon, 85925, France

Location

Hospices Civils de Lyon - Hôpital Louis Pradel

Lyon, 69000, France

Location

CHU La Timone

Marseille, 13000, France

Location

ICO RenéGauducheau

Nantes, 44000, France

Location

CH Nimes - Institut de Cancérologie du Gard

Nîmes, 30000, France

Location

Institut Curie Paris

Paris, 75005, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

INSTITUT CURIE - Site René Huguenin St Cloud

Saint-Cloud, 92000, France

Location

HIA Begin

Saint-Mandé, 94160, France

Location

Related Publications (1)

• 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.

  PMID: 33036567 DERIVED

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Florence JOLY, MD PhD

  Centre François Baclesse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 30, 2017
• Study Start: July 11, 2017
• Primary Completion: September 30, 2024
• Study Completion (Estimated): July 11, 2028
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (15)