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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

Tracking Information
First Submitted Date  ICMJE February 6, 2014
First Posted Date  ICMJE May 9, 2014
Last Update Posted Date August 21, 2017
Actual Study Start Date  ICMJE July 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
  • 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)
  • Quality of life [ Time Frame: 3 months after the end of radiotherapy ]
    "Performance status" (Karnofsky) 3 months after the end of radiotherapy.
  • 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).
  • Quality of life [ Time Frame: 3 months after the end of radiotherapy ]
    Decrease addiction to 3 months after the end of radiotherapy (Declarative).
  • Quality of life [ Time Frame: 3 months after the end of radiotherapy ]
    Rate of feasibility of the protocol.
  • Quality of life [ Time Frame: 3 months after the end of radiotherapy ]
    Identification of indicator (s) to monitor the APA.
  • Quality of life [ Time Frame: 3 months after the end of radiotherapy ]
    Evaluation of precariousness (EPICES).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of the Rehabilitation Effort at Home in Patients With Head and Neck Tumor Treated With Curative Intent
Official Title  ICMJE 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
Brief Summary Improvement exercise tolerance
Detailed Description This study allows improved exercise tolerance in patients undergoing rehabilitation effort
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE
  • Other: custom work endurance
    Experimental: Rehabilitation effort
  • Behavioral: dietary management adapted to the nutritional status
    dietary management adapted to the nutritional status
Study Arms  ICMJE
  • 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
    Intervention: Other: custom work endurance
  • Active Comparator: Control
    Control with dietary management adapted to the nutritional status
    Intervention: Behavioral: dietary management adapted to the nutritional status
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2014)
70
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02135185
Other Study ID Numbers  ICMJE VA2011/43
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut du Cancer de Montpellier - Val d'Aurelle
Study Sponsor  ICMJE Institut du Cancer de Montpellier - Val d'Aurelle
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pierre SENESSE ICM Co. Ltd.
PRS Account Institut du Cancer de Montpellier - Val d'Aurelle
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP