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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03169075
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : May 6, 2020
Sponsor:
Collaborator:
CAMI: Sport & Cancer
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Home Based Standardised Adapted Physical Activity Programme Patients Taking Oral Targeted Therapy for Metastatic Cancer Behavioral: Supervised physical exercise programs Behavioral: Adapted physical activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : July 11, 2017
Estimated Primary Completion Date : October 11, 2020
Estimated Study Completion Date : July 11, 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ARM A: A
Supervised physical exercise programs (SPEP)
Behavioral: Supervised physical exercise programs

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


Active Comparator: ARM B: B
Adapted physical activity (APA)
Behavioral: Adapted physical activity

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





Primary Outcome Measures :
  1. FACT-F relative on Fatigue [ Time Frame: Month 3 ( M3) ]
    Self reported Questionnaires

  2. FACT-G [ Time Frame: Month3 ( M3) ]
    Self Reported Questionnaire relative on Well-Being Patient


Secondary Outcome Measures :
  1. PFS [ Time Frame: 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

  2. OS [ Time Frame: 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

  3. Quality of life [ Time Frame: Month 1, Month 2, Month 3, and every 3 months for 1 year ]
    Self reported Questionnaire on quality of life

  4. Fatigue [ Time Frame: Month 1, Month 2, Month 3, and every 3 months for 1 year ]
    Self reported Questionnaire FACT-F on Fatigue

  5. Fatigue [ Time Frame: Month 1, Month 2, Month 3, and every 3 months for 1 year ]
    visual analogic scale for fatigue

  6. Pain [ Time Frame: Month 1, Month 2, Month 3, and every 3 months for 1 year ]
    visual analogic scale for pain (VAS)

  7. Toxicities Secondaries effectsToxicities according NCI-CTC (National Cancer Institute Updates CTCAE to v.4.03. Common Terminology Criteria ) [ Time Frame: Baseline, Month 1, Month 2, Month 3, and every 3 months for 1 year ]
    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).

  8. Compliance about oral targeted therapy [ Time Frame: Baseline, Month 1, Month 2, Month 3 ]
    Self reported Questionnaire Morisky-Green

  9. Benefit of physical activity: walk [ Time Frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year ]
    6 minutes walking test

  10. Benefit of physical activity muscle function [ Time Frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year ]
    muscle function

  11. Benefit of physical activity muscle strength [ Time Frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year ]
    muscle strength

  12. Physical Activity IPAQ [ Time Frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year ]
    self reported Questionnaire IPAQ ( International Physical Activity Questionnaire)

  13. Physical Activity, Body Mass Index [ Time Frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year ]
    Body Mass Index

  14. Scores of anxiety and depression [ Time Frame: Baseline, Month 1, Month 2, Month 3 ]
    Hospital Anxiety and Depression Scale (HADs)

  15. Cognitive functions [ Time Frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year ]
    Self reported questionnaire FACT-Cog

  16. Evaluation of Ingesta, Anorexia [ Time Frame: Baseline, Month 3 ]
    Ingesta

  17. Evaluation of Ingesta, VAS [ Time Frame: Baseline, Month 3 ]
    VAS

  18. Evaluation of Anorexia [ Time Frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year ]
    Self reported FAACT (module A-C)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03169075


Contacts
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Contact: Florence JOLY, MD PhD +33 (0) 2 31 45 50 02 f.joly@baclesse.unicancer.fr
Contact: Isabelle RIEGER i-rieger@unicancer.fr

Locations
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France
ICO Paul Papin Not yet recruiting
Angers, France, 49000
Contact: Sophie ABADIE-LACOURTOISIE, MD PhD         
CH Annecy Genevois - site d'Annecy Not yet recruiting
Annecy, France, 74474
Contact: Laetitia Stefani, MD PhD         
CHRU de Besançon Recruiting
Besançon, France, 25000
Contact: Nathalie Meneveau, MD PhD         
Centre François Baclesse Recruiting
Caen, France, 14076
Contact: Florence Joly, MD PhD         
CH de Cholet Not yet recruiting
Cholet, France, 49300
Contact: Alain Zenatti         
GHMG - Institut Daniel Hollard Not yet recruiting
Grenoble, France, MD Phd
Contact: Claire GARNIER-TIXIDRE         
CHD Vendée Not yet recruiting
La Roche-sur-Yon, France, 85925
Contact: Véronique GIRRE, MD PhD         
Hospices Civils de Lyon - Hôpital Louis Pradel Not yet recruiting
Lyon, France, 69000
Contact: Bénédicte Mastroianni         
CHU La Timone Not yet recruiting
Marseille, France, 13000
Contact: Sébastien SALAS, MD PhD         
ICO RenéGauducheau Not yet recruiting
Nantes, France, 44000
Contact: Sophie ABADIE-LACOURTOISIE, MD PhD         
CH Nimes - Institut de Cancérologie du Gard Not yet recruiting
Nîmes, France, 30000
Contact: Nadine HOUEDE, MD PhD         
Institut Curie Paris Not yet recruiting
Paris, France, 75005
Contact: Claude BOIRON, PhD         
Centre Eugène Marquis Recruiting
Rennes, France, 35042
Contact: Claudia LEFEUVRE-PLESSE, MD PhD         
INSTITUT CURIE - Site René Huguenin St Cloud Not yet recruiting
Saint-Cloud, France, 92000
Contact: Claude Boiron, MD PhD         
HIA Begin Not yet recruiting
Saint-Mandé, France, 94160
Contact: Carole Helissey, MD PhD         
Sponsors and Collaborators
UNICANCER
CAMI: Sport & Cancer
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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT03169075    
Other Study ID Numbers: UC-0106/1510 SdS 01 QUALIOR
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UNICANCER:
Adapted physical activity
Oral targeted therapy
Advanced cancer
Fatigue
Quality of life
Randomized Study
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes