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Spots Global Cancer Trial Database for Evaluation of an Active Swallowing Rehabilitation on Quality of Life of Patients Treated by Radiotherapy for Head and Neck Cancer

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Trial Identification

Brief Title: Evaluation of an Active Swallowing Rehabilitation on Quality of Life of Patients Treated by Radiotherapy for Head and Neck Cancer

Official Title: Evaluation of an Active Swallowing Rehabilitation on Quality of Life of Patients Treated by Radiotherapy for Head and Neck Cancer

Study ID: NCT02892487

Interventions

Swallowing therapy

Study Description

Brief Summary: 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. 1. 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. 2. 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Brest University Hospital, Brest, , France

Caen University Hospital, Caen, , France

Centre François Baclesse, Caen, , France

Clermont-Ferrand University Hospital, Clermont-Ferrand, , France

Le Mans Hospital, Le Mans, , France

Lille University Hospital, Lille, , France

Bretagne Sud Hospital, Lorient, , France

Lyon University Hospital, Lyon, , France

Marseille University Hospital, Marseille, , France

Centre Alexis Vautrin, Nancy, , France

Nantes University Hospital, Nantes, , France

Centre Antoine Lacassagne, Nice, , France

Tenon Hospital, Paris, , France

Poitiers University Hospital, Poitiers, , France

Clinique La Sagesse, Rennes, , France

Rennes University Hospital, Rennes, , France

Strasbourg University Hospital, Strasbourg, , France

Toulouse University Hospital, Toulouse, , France

Tours University Hospital, Tours, , France

Bretagne Atlantique Hospital, Vannes, , France

Institut Gustave Roussy, Villejuif, , France

Contact Details

Name: Franck JEGOUX

Affiliation: Rennes University Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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