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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02135185

Acronym

NUTRIMOUV

Enrollment

Registered

2014-05-09

Start date

2012-07-31

Completion date

2016-06-30

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Brief summary

Improvement exercise tolerance

Detailed description

This study allows improved exercise tolerance in patients undergoing rehabilitation effort

Interventions

OTHERcustom work endurance

Experimental: Rehabilitation effort

BEHAVIORALdietary management adapted to the nutritional status

dietary management adapted to the nutritional status

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026