NCT02135185

Brief Summary

Improvement exercise tolerance

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_2 head-and-neck-cancer

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 9, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

3.4 years

First QC Date

February 6, 2014

Last Update Submit

August 16, 2017

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

    up to 24 weeks

Secondary Outcomes (7)

  • Quality of life

    3 months after the end of radiotherapy

  • Quality of life

    3 months after the end of radiotherapy

  • Quality of life

    3 months after the end of radiotherapy

  • Quality of life

    3 months after the end of radiotherapy

  • Quality of life

    3 months after the end of radiotherapy

  • +2 more secondary outcomes

Study Arms (2)

Rehabilitation effort

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

Control with dietary management adapted to the nutritional status

Behavioral: dietary management adapted to the nutritional status

Interventions

custom work enduranceOTHER

Experimental: Rehabilitation effort

Rehabilitation effort
dietary management adapted to the nutritional statusBEHAVIORAL

dietary management adapted to the nutritional status

Control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut régional du Cancer - Montpellier - Val d'Aurelle

Montpellier, 34298, France

Location

Related Publications (1)

  • Vinches M, Janiszewski C, Thezenas S, Delample D, Boisselier P, Jacquot S, Senesse P, Faravel K. Evaluation of physical rehabilitation in patients receiving curative treatment for head and neck cancer: The NUTRIMOUV randomized phase II trial. Support Care Cancer. 2025 Dec 16;34(1):35. doi: 10.1007/s00520-025-10265-7.

    PMID: 41400716DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Pierre SENESSE

    ICM Co. Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2014

First Posted

May 9, 2014

Study Start

July 1, 2012

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

August 21, 2017

Record last verified: 2017-08

Locations

FR(1)