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Completed

NCT Number: NCT02135185

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

Improvement exercise tolerance

Completed

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institut régional du Cancer - Montpellier - Val d'Aurelle

Montpellier, 34298, France

About this study

This study allows improved exercise tolerance in patients undergoing rehabilitation effort

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

custom work endurance

Other

Experimental: Rehabilitation effort

dietary management adapted to the nutritional status

Behavioral

dietary management adapted to the nutritional status

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study 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

Acronym: NUTRIMOUV

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
May 9, 2014
Registry last updated
Aug 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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