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

NCT ID: NCT02892487

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-09
• Study Completion Date: 2021-06-30

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.

Conditions

Cancer of Head and Neck

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Early active swallowing therapy

Group Type: EXPERIMENTAL

Swallowing therapy

Intervention Type: OTHER

Patients will undergo active swallowing therapy with a speech and language therapist (twice a week) combined to a detailed program of swallowing auto-exercises (twice a day) from start of radiotherapy to one month after the end.

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Swallowing therapy

Patients will undergo active swallowing therapy with a speech and language therapist (twice a week) combined to a detailed program of swallowing auto-exercises (twice a day) from start of radiotherapy to one month after the end.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient treated for histologically proven head and neck cancer (oral cavity, oropharynx, or hypopharynx cancer) of stages I-IV or larynx cancer of stages II-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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Franck JEGOUX

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

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

Countries

France

Other Identifiers

35RC14_9786_RORC

Identifier Type: -

Identifier Source: org_study_id