Back to resultsEffect of the Rehabilitation Effort at Home in Patients With Head and Neck Tumor Treated With Curative Intent (NUTRIMOUV)
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
custom work endurance
dietary management adapted to the nutritional status
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Cancer
Eligibility Criteria
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
Sites / Locations
- Institut régional du Cancer - Montpellier - Val d'Aurelle
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rehabilitation effort
Control
Arm 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
Control with dietary management adapted to the nutritional status
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Quality of life
Quality of life 3 months after the end of radiotherapy (QLQ C30 and SF 36)
Quality of life
"Performance status" (Karnofsky) 3 months after the end of radiotherapy.
Quality of life
Quantity of daily physical activity to 3 months after the end of radiotherapy (Actimeter).
Quality of life
Decrease addiction to 3 months after the end of radiotherapy (Declarative).
Quality of life
Rate of feasibility of the protocol.
Quality of life
Identification of indicator (s) to monitor the APA.
Quality of life
Evaluation of precariousness (EPICES).
Full Information
NCT ID
NCT02135185
First Posted
February 6, 2014
Last Updated
August 16, 2017
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
1. Study Identification
Unique Protocol Identification Number
NCT02135185
Brief Title
Effect of the Rehabilitation Effort at Home in Patients With Head and Neck Tumor Treated With Curative Intent
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Improvement exercise tolerance
Detailed Description
This study allows improved exercise tolerance in patients undergoing rehabilitation effort
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rehabilitation effort
Arm Type
Experimental
Arm 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
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control with dietary management adapted to the nutritional status
Intervention Type
Other
Intervention Name(s)
custom work endurance
Intervention Description
Experimental: Rehabilitation effort
Intervention Type
Behavioral
Intervention Name(s)
dietary management adapted to the nutritional status
Intervention Description
dietary management adapted to the nutritional status
Primary Outcome Measure Information:
Title
measurement of the increase of initial endurance
Description
Patients increasing rate of at least 40% of their initial endurance time 3 months after the completion of radiotherapy
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Quality of life
Description
Quality of life 3 months after the end of radiotherapy (QLQ C30 and SF 36)
Time Frame
3 months after the end of radiotherapy
Title
Quality of life
Description
"Performance status" (Karnofsky) 3 months after the end of radiotherapy.
Time Frame
3 months after the end of radiotherapy
Title
Quality of life
Description
Quantity of daily physical activity to 3 months after the end of radiotherapy (Actimeter).
Time Frame
3 months after the end of radiotherapy
Title
Quality of life
Description
Decrease addiction to 3 months after the end of radiotherapy (Declarative).
Time Frame
3 months after the end of radiotherapy
Title
Quality of life
Description
Rate of feasibility of the protocol.
Time Frame
3 months after the end of radiotherapy
Title
Quality of life
Description
Identification of indicator (s) to monitor the APA.
Time Frame
3 months after the end of radiotherapy
Title
Quality of life
Description
Evaluation of precariousness (EPICES).
Time Frame
3 months after the end of radiotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre SENESSE
Organizational Affiliation
ICM Co. Ltd.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut régional du Cancer - Montpellier - Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
12. IPD Sharing Statement
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Effect of the Rehabilitation Effort at Home in Patients With Head and Neck Tumor Treated With Curative Intent
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