Effect of the Rehabilitation Effort at Home in Patients With Head and Neck Tumor Treated With Curative Intent

Study Overview
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Brief Summary
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Improvement exercise tolerance

Detailed Description
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This study allows improved exercise tolerance in patients undergoing rehabilitation effort

Official Title
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Phase II Study, Multicentric, Randomized Studying the Effect of the Rehabilitation Effort at Home in Patients With Head and Neck Tumor Treated With Curative Intent

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Other: custom work endurance
* Behavioral: dietary management adapted to the nutritional status


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Tumor squamous cell head and neck (excluding nasopharynx) nonmetastatic including cervical lymphadenopathy primitives 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: Cancer of the nasopharynx 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rehabilitation effort<br>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 | Other: custom work endurance<br>* Experimental: Rehabilitation effort<br>|
| Active Comparator: Control<br>Control with dietary management adapted to the nutritional status | Behavioral: dietary management adapted to the nutritional status<br>* dietary management adapted to the nutritional status<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of the increase of initial endurance | Patients increasing rate of at least 40% of their initial endurance time 3 months after the completion of radiotherapy | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life 3 months after the end of radiotherapy (QLQ C30 and SF 36) | 3 months after the end of radiotherapy | 
| Quality of life | Performance status (Karnofsky) 3 months after the end of radiotherapy. | 3 months after the end of radiotherapy | 
| Quality of life | Quantity of daily physical activity to 3 months after the end of radiotherapy (Actimeter). | 3 months after the end of radiotherapy | 
| Quality of life | Decrease addiction to 3 months after the end of radiotherapy (Declarative). | 3 months after the end of radiotherapy | 
| Quality of life | Rate of feasibility of the protocol. | 3 months after the end of radiotherapy | 
| Quality of life | Identification of indicator (s) to monitor the APA. | 3 months after the end of radiotherapy | 
| Quality of life | Evaluation of precariousness (EPICES). | 3 months after the end of radiotherapy |