Etude : RORC /

ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.

Acronyme / Nom
Situation thérapeutique
Cadre réglementaire
Présentation de l'étude
Acronyme / Nom : RORC

Situation thérapeutique :

Traitement : Radiothérapie

Cadre réglementaire : RIPH2

Dernière MÀJ : 16/03/2022
CIM10 - Localisation(s)
Informations principales
Titre : Évaluation d'une rééducation active de la déglutition sur la qualité de vie chez les patients traités par radiothérapie pour un cancer des voies aéro-digestives supérieures

Spécialité : Lèvre, cavité buccale et pharynx
Localisation : C06 - Tumeur maligne de la bouche, parties autres et non précisées

Spécialité : Lèvre, cavité buccale et pharynx
Localisation : C10 - Tumeur maligne de l'oropharynx

Spécialité : Lèvre, cavité buccale et pharynx
Localisation : C13 - Tumeur maligne de l'hypopharynx

Spécialité : Organes respiratoires et intrathoraciques
Localisation : C32 - Tumeur maligne du larynx
Informations complémentaires
Schéma : Toxicity and mainly dysphagia have increased in head and neck cancers as chemoradiation indications have risen over the last decade, leading to a significant loss of quality of life for patients. Recently, many retrospective studies and two evidence-based and systematic reviews on strategies to reduce radiation-induced dysphagia have suggested a trend toward benefit for a preventive swallowing exercise program.

The main hypothesis of this study is that an early active swallowing therapy can improve the Quality of Life (QoL) of patients treated by radiotherapy for head and neck cancer.

The study will be a randomized controlled, open-label, multicentric phase III clinical trial comparing early active swallowing therapy versus non specific swallowing management (usual care).

Detailed Description:
Patients in both groups will receive dietary and postural advice from the treating physician. Patients in the experimental group will be treated with an early active swallowing therapy including a consultation with a speech and language therapist twice a week and a detailed program of swallowing auto-exercises twice a day, from the start to one month after the end of radiotherapy. All speech therapists will be given precise guidelines based on the current state of the art and knowledge. All patients will be analyzed in intent-to-treat.

Two ancillary studies will complete this global concept of the evaluation and prediction of severe alteration of Quality of Life (QoL) and Dysphagia:
-> A first study will evaluate videoradioscopy. Its objectives are to evaluate the ability of videoradioscopy at 3 months to predict poor QoL at 6 and 12 months, to identify videoradioscopic predictors of severe dysphagia, asymptomatic aspirations, cricopharyngeal stenoses and active swallowing rehabilitation efficiency. Each patient of both arms of the main study will undergo a videoradioscopy before the beginning of the radiation delivery (baseline evaluation), and at 3 and at 12 months. Data analysis will be centralized and will concern: APS (Aspiration and Penetration Scale) score, residue, Defective Laryngeal elevation, pharyngoesophageal sphincter dysfunction. Data will be correlated to the parameters of the main study in order to establish predictive models.
-> A second ancillary study will evaluate the dose-volume histograms of radiotherapy. The objectives are to identify predictors of dysphagia and of active swallowing rehabilitation efficiency, and to establish "2D" and "3D" predictive models of dysphagia. Imaging and dosimetric data (IMRT (Intensity Modified RadioTherapy) planning) and dose-volume histogram will be collected from the patients of the main clinical trial. Analysis will be centralized. Data will be correlated to the parameters of the main study in order to establish predictive models.

Phase : NA

Stade : NA

Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Patient treated for histologically proven head and neck cancer (oral cavity, oropharynx, hypopharynx, or larynx cancer), stages I-IV, all histologic type, without distant metastasis
- Indication of curative radiotherapy alone or associated to chemotherapy or targeted therapy, without planned surgery
- WHO (World Health Organization) Performance Status 0, 1 or 2
- Sufficient cognitive capacities to complete a QoL questionnaire (evaluation by the physician at inclusion)
- Written informed consent
- Patients with health insurance

Critères de non-inclusion : - Previous radiotherapy or surgery of the upper aerodigestive tract
- Cancer of paranasal sinuses or nasopharynx or skull base
- Medical history of nervous system disease associated to significant sequelae in terms of dysphagia
- Pregnant or breast-feeding woman
- Patient under guardianship, trusteeship or judicial protection
Informations relatives au promoteur
Promoteur :
CHU de Rennes
Type de sponsor : Institutionnel
35000 RENNES

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN

Investigateur :


Statut de l'essai : CLOS

MAJ : 16/03/2022

Centre investigateur :
CHU de Caen - Avenue de la Côte de Nacre - 14033 Caen Cedex - 14000 CAEN

Investigateur :
Emmanuel BABIN


Statut de l'essai : CLOS

MAJ : 16/03/2022