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Rehabilitation by Effort for Patients With Advanced Bronchial Cancer (RehabKBP)

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: NCT03684486
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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Brief Summary:

Bronchopulmonary cancers or mesothelioma are associated with effort deconditioning due to pathology (chronic inflammation) and also to treatments (surgery, radiotherapy, chemotherapy); it's considerably alters patients quality of life.

Investigators want to ensured the feasibility of rehabilitation by effort for these patients.


Condition or disease Intervention/treatment Phase
Bronchial Cancer Malignant Mesothelioma Behavioral: rehabilitation by effort Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Rehabilitation by Effort for Patients With Advanced Bronchial Cancer
Actual Study Start Date : February 1, 2012
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: rehabilitation by effort
8 sessions of rehabilitation by effort in sports medicine
 Behavioral: rehabilitation by effort


Outcome Measures
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Primary Outcome Measures :
  1. patients who completed at least 6 sessions of rehabilitation [ Time Frame: 10 years ]
    number of patients who completed at least 6 sessions of rehabilitation by effort


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • General condition according to World Health Organisation 0-1
  • Age between 18 and 70 years old
  • Non progressive patients according to RECIST criteria 1.1 after chemotherapy treatment whichever line of treatment
  • Autonomous patient
  • Voluntary written informed consent signed
  • Patients with social security insurance

Exclusion Criteria:

  • Bone metastasis with fracture risk
  • Significant cardiovascular pathology
  • Cardiac, vascular, rheumatologic or neurologic contraindication
  • Patients living far 60 kms from Toulouse
  • Patients under juridical protection guardianship, or tutelage measure
Contacts and Locations
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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): NCT03684486


Contacts
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Contact: Julien MAZIERES, MD PhD 05 67 77 18 37 ext +33 mazieres.j@chu-toulouse.fr

Locations
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France
CHU de Toulouse Recruiting
Toulouse, France, 31059
Contact: Julien MAZIERES, PhD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Julien Mazières, MD PhD University Hospital, Toulouse
More Information
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03684486    
Other Study ID Numbers: RC31/11/0087
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020

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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 University Hospital, Toulouse:
bronchial cancer
rehabilitation
Additional relevant MeSH terms:
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Mesothelioma
Mesothelioma, Malignant
Carcinoma, Bronchogenic
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
 Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Pleural Neoplasms
Lung Diseases
Respiratory Tract Diseases
Bronchial Neoplasms