Effect of the Rehabilitation Effort at Home in Patients With Head and Neck Tumor Treated With Curative Intent
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: custom work endurance Type: Other
Name: dietary management adapted to the nutritional status Type: Behavioral
Overall Status
Recruiting
Summary
Improvement exercise tolerance
Detailed Description
This study allows improved exercise tolerance in patients undergoing rehabilitation effort
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Institut régional du Cancer - Montpellier - Val d'Aurelle
Montpellier, France
Status: Recruiting
Contact: BLEUSE Jean-pierre - 0033467613102 - jean-pierre.bleuse@icm.unicancer.fr
Start Date
July 2012
Completion Date
June 2016
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Source
Institut du Cancer de Montpellier - Val d'Aurelle
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page