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

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

Improvement exercise tolerance

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Other: custom work endurance; Behavioral: dietary management adapted to the nutritional status

Detailed Description

This study allows improved exercise tolerance in patients undergoing rehabilitation effort

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34298
    • Institut régional du Cancer - Montpellier - Val d'Aurelle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rehabilitation effort; 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; Experimental: Rehabilitation effort
Active Comparator: Control; Control with dietary management adapted to the nutritional status	Behavioral: dietary management adapted to the nutritional status; dietary management adapted to the nutritional status

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Investigators: Principal Investigator: Pierre SENESSE, ICM Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: February 6, 2014
• First Submitted That Met QC Criteria: May 8, 2014
• First Posted (Estimate): May 9, 2014

Study Record Updates

• Last Update Posted (Actual): August 21, 2017
• Last Update Submitted That Met QC Criteria: August 16, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: VA2011/43