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

Phase 2

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT02135185
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Brief Summary

Improvement exercise tolerance

Detailed Description

This study allows improved exercise tolerance in patients undergoing rehabilitation effort

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2014-02-06
• Study First Submitted QC: 2014-05-08
• Study First Posted: 2014-05-09
• Primary Completion: 2015-12
• Study Completion: 2016-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
measurement of the increase of initial endurance	up to 24 weeks	Patients increasing rate of at least 40% of their initial endurance time 3 months after the completion of radiotherapy

Secondary Outcome Measures

Name	Time	Method
Quality of life	3 months after the end of radiotherapy	Evaluation of precariousness (EPICES).

Trial Locations

Locations (1)

Institut régional du Cancer - Montpellier - Val d'Aurelle; 🇫🇷 Montpellier, France