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

Institut du Cancer de Montpellier - Val d'Aurelle

Status and phase: Completed; Phase 2

Conditions: Head and Neck Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02135185

VA2011/43

Details and patient eligibility

About

Improvement exercise tolerance

Full description

This study allows improved exercise tolerance in patients undergoing rehabilitation effort

Enrollment: 70 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Rehabilitation effort

Experimental group

Description:

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

Treatment:

Other: custom work endurance

Control

Active Comparator group

Description:

Control with dietary management adapted to the nutritional status

Treatment:

Behavioral: dietary management adapted to the nutritional status