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

• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle (Other)
• Overall Status: Completed
• CT.gov ID: NCT02135185
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 47
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

Improvement exercise tolerance

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Other: custom work endurance; Behavioral: dietary management adapted to the nutritional status	Phase 2

Detailed Description

This study allows improved exercise tolerance in patients undergoing rehabilitation effort

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Quality of life [3 months after the end of radiotherapy]

   Quality of life 3 months after the end of radiotherapy (QLQ C30 and SF 36)

2. Quality of life [3 months after the end of radiotherapy]

   "Performance status" (Karnofsky) 3 months after the end of radiotherapy.

3. Quality of life [3 months after the end of radiotherapy]

   Quantity of daily physical activity to 3 months after the end of radiotherapy (Actimeter).

4. Quality of life [3 months after the end of radiotherapy]

   Decrease addiction to 3 months after the end of radiotherapy (Declarative).

5. Quality of life [3 months after the end of radiotherapy]

   Rate of feasibility of the protocol.

6. Quality of life [3 months after the end of radiotherapy]

   Identification of indicator (s) to monitor the APA.

7. Quality of life [3 months after the end of radiotherapy]

   Evaluation of precariousness (EPICES).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut régional du Cancer - Montpellier - Val d'Aurelle	Montpellier		France	34298

Sponsors and Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

• Principal Investigator: Pierre SENESSE, ICM Co. Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
• ClinicalTrials.gov Identifier: NCT02135185
• Other Study ID Numbers: VA2011/43
• First Posted: May 9, 2014
• Last Update Posted: Aug 21, 2017
• Last Verified: Aug 1, 2017

• Additional relevant MeSH terms: Head and Neck Neoplasms

Study Results

No Results Posted as of Aug 21, 2017