Head and Neck CancerPhase 2NUTRIMOUVNCT02135185
Effect of the Rehabilitation Effort at Home in Patients With Head and Neck Tumor Treated With Curative Intent
A Phase 2 study testing custom work endurance and dietary management adapted to the nutritional status in people with Head and Neck Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
Improvement exercise tolerance Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- custom work endurance and dietary management adapted to the nutritional status
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2012to Jun 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Institut régional du Cancer - Montpellier - Val d'Aurelle
Montpellier, 34298
About this study
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
Improvement exercise tolerance
Read the detailed description
This study allows improved exercise tolerance in patients undergoing rehabilitation effort
- Conditions
- Head and Neck Cancer
- Being tested
- custom work endurance, dietary management adapted to the nutritional status
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
custom work enduranceOther
Experimental: Rehabilitation effort
dietary management adapted to the nutritional statusBehavioural
dietary management adapted to the nutritional status
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: custom work endurance |
| Control | Active comparator | Control with dietary management adapted to the nutritional status Receives: Behavioral: dietary management adapted to the nutritional status |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 24 weeks
Secondary outcomes (7)
Quality of life
Quality of life 3 months after the end of radiotherapy (QLQ C30 and SF 36)
Measured: 3 months after the end of radiotherapy
Quality of life
"Performance status" (Karnofsky) 3 months after the end of radiotherapy.
Measured: 3 months after the end of radiotherapy
Quality of life
Quantity of daily physical activity to 3 months after the end of radiotherapy (Actimeter).
Measured: 3 months after the end of radiotherapy
Quality of life
Decrease addiction to 3 months after the end of radiotherapy (Declarative).
Measured: 3 months after the end of radiotherapy
Quality of life
Rate of feasibility of the protocol.
Measured: 3 months after the end of radiotherapy
Quality of life
Identification of indicator (s) to monitor the APA.
Measured: 3 months after the end of radiotherapy
Quality of life
Evaluation of precariousness (EPICES).
Measured: 3 months after the end of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startJul 2012
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre SENESSE, Principal investigator, ICM Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135185
- Sponsor's protocol ID
- VA2011/43
- Acronym
- NUTRIMOUV
- Status last verified
- Aug 2017
- First submitted
- 6 Feb 2014
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 41400716
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02135185
- Acronym / sponsor ID
- NUTRIMOUV / VA2011/43
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- Jul 2012 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 9 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Improvement exercise tolerance
Detailed description
This study allows improved exercise tolerance in patients undergoing rehabilitation effort
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation effort | Experimental | Other: custom work endurancecustom 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 |
| Control | Active comparator | Behavioral: dietary management adapted to the nutritional statusControl with dietary management adapted to the nutritional status |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- Cancer of the nasopharynx
- Metastatic Patient
- Patients who received neoadjuvant chemotherapy or induction
- Patient parenteral nutrition
- Non-compliant Patient Treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| custom work enduranceExperimental: Rehabilitation effort | Other | Rehabilitation effort |
| dietary management adapted to the nutritional statusdietary management adapted to the nutritional status | Behavioural | Control |
Primary outcome
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
7 secondary outcomes
Quality of life
Time frame: 3 months after the end of radiotherapy
Quality of life
Time frame: 3 months after the end of radiotherapy
Quality of life
Time frame: 3 months after the end of radiotherapy
Quality of life
Time frame: 3 months after the end of radiotherapy
Quality of life
Time frame: 3 months after the end of radiotherapy
Quality of life
Time frame: 3 months after the end of radiotherapy
Quality of life
Time frame: 3 months after the end of radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Derived from this study: PubMed 41400716Vinches 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre SENESSE principal investigator
ICM Co. Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing custom work endurance and dietary management adapted to the nutritional status in people with Head and Neck Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of the increase of initial endurance (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02135185, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2017.