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

Head and Neck Cancer Clinical Trial

— NUTRIMOUV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02135185
• Other study ID #: VA2011/43
• Status: Completed
• Phase: Phase 2
• First received: February 6, 2014
• Last updated: August 16, 2017
• Start date: July 2012
• Est. completion date: June 2016

Study information

• Verified date: August 2017
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Improvement exercise tolerance

Description:

This study allows improved exercise tolerance in patients undergoing rehabilitation effort

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• custom work endurance
Experimental: Rehabilitation effort

Behavioral:
• dietary management adapted to the nutritional status
dietary management adapted to the nutritional status

Locations

Country	Name	City	State
France	Institut régional du Cancer - Montpellier - Val d'Aurelle	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Quality of life	"Performance status" (Karnofsky) 3 months after the end of radiotherapy.	3 months after the end of radiotherapy
Secondary	Quality of life	Quantity of daily physical activity to 3 months after the end of radiotherapy (Actimeter).	3 months after the end of radiotherapy
Secondary	Quality of life	Decrease addiction to 3 months after the end of radiotherapy (Declarative).	3 months after the end of radiotherapy
Secondary	Quality of life	Rate of feasibility of the protocol.	3 months after the end of radiotherapy
Secondary	Quality of life	Identification of indicator (s) to monitor the APA.	3 months after the end of radiotherapy
Secondary	Quality of life	Evaluation of precariousness (EPICES).	3 months after the end of radiotherapy