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
• Interventions: Other: custom work endurance; Behavioral: dietary management adapted to the nutritional status

• 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

Arm && Interventions

Group	Intervention	Description
Rehabilitation effort	custom work endurance	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
Control	dietary management adapted to the nutritional status	Control with dietary management adapted to the nutritional status

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