Clinical trial · Interventional
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
NCT02135185CI-TRIAL-00029156NUTRIMOUVcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Improvement exercise tolerance
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| custom work endurance | Other | — | UNRESOLVED |
| dietary management adapted to the nutritional status | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Rehabilitation effort
- description
- 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
- interventionNames
- Other: custom work endurance
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Control with dietary management adapted to the nutritional status
- interventionNames
- Behavioral: dietary management adapted to the nutritional status
Primary outcomes (1)
- measure
- measurement of the increase of initial endurance
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDVinches 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 41400716