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

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ClinicalTrials.gov Identifier: NCT02135185
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : August 21, 2017
Sponsor:
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle

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

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Study Type : Interventional  (Clinical Trial)
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 : July 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. measurement of the increase of initial endurance [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 months after the end of radiotherapy ]
    "Performance status" (Karnofsky) 3 months after the end of radiotherapy.

  3. Quality of life [ Time Frame: 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 [ Time Frame: 3 months after the end of radiotherapy ]
    Decrease addiction to 3 months after the end of radiotherapy (Declarative).

  5. Quality of life [ Time Frame: 3 months after the end of radiotherapy ]
    Rate of feasibility of the protocol.

  6. Quality of life [ Time Frame: 3 months after the end of radiotherapy ]
    Identification of indicator (s) to monitor the APA.

  7. Quality of life [ Time Frame: 3 months after the end of radiotherapy ]
    Evaluation of precariousness (EPICES).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135185


Locations
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France
Institut régional du Cancer - Montpellier - Val d'Aurelle
Montpellier, France, 34298
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
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Principal Investigator: Pierre SENESSE ICM Co. Ltd.
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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    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms