Effect of the Rehabilitation Effort at Home in Patients With Head and Neck Tumor Treated With Curative Intent
NCT ID: NCT02135185
Last Updated: 2017-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2012-07-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Rehabilitation effort
custom work endurance combining dietary management adapted to the nutritional status and an APA. Included patients benefit from support for 19 weeks from the start of treatment
custom work endurance
Experimental: Rehabilitation effort
Control
Control with dietary management adapted to the nutritional status
dietary management adapted to the nutritional status
dietary management adapted to the nutritional status
Interventions
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custom work endurance
Experimental: Rehabilitation effort
dietary management adapted to the nutritional status
dietary management adapted to the nutritional status
Eligibility Criteria
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Inclusion Criteria
* Patient to be treated with curative radiotherapy monofractionnée for at least 6 weeks, with or without concurrent chemotherapy (including targeted therapies)
* KPS ≥ 60
Exclusion Criteria
* Metastatic Patient
* Patients who received neoadjuvant chemotherapy or induction
* Patient parenteral nutrition
* Non-compliant Patient Treatment
* Patient with a cons-indication to the achievement of an effort: clinical signs of pulmonary arterial hypertension (PAH) uncontrolled heart failure, recent myocardial infarction, arrhythmias, unstable angina.
* Patient desaturation in the stress test
* Patient already included in another clinical trial with an experimental molecule
* Pacemaker or defibrillator or neurostimulator
* Contraindications to treatment with standard radiotherapy with or without concurrent chemotherapy
18 Years
75 Years
ALL
No
Sponsors
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Institut du Cancer de Montpellier - Val d'Aurelle
OTHER
Responsible Party
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Principal Investigators
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Pierre SENESSE
Role: PRINCIPAL_INVESTIGATOR
ICM Co. Ltd.
Locations
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Institut régional du Cancer - Montpellier - Val d'Aurelle
Montpellier, , France
Countries
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Other Identifiers
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VA2011/43
Identifier Type: -
Identifier Source: org_study_id
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