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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02892487
Other study ID # 35RC14_9786_RORC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 9, 2016
Est. completion date January 2022

Study information

Verified date June 2018
Source Rennes University Hospital
Contact Claire LAFOREST
Phone +33 (0)2 99 28 98 97
Email claire.laforest@chu-rennes.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 420
Est. completion date January 2022
Est. primary completion date July 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
France 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

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients experiencing a clinically relevant improvement defined as a decrease of at least 10 points of the score HNSW ( 6 months after radiotherapy compared with the score before radiotherapy HNSW = Head and Neck Swallowing Questionnaire 6 months after radiotherapy
Secondary EORTC QLQ-C30 score EORTC QLQ = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Baseline, 3, 6 and 12 months after radiotherapy
Secondary EORTC H&N35 score EORTC H&N = European Organisation for Research and Treatment of Cancer Head and Neck questionnaire Baseline, 3, 6 and 12 months after radiotherapy
Secondary MFI-20 score MFI = Multidimensional Fatigue Inventory Baseline, 3, 6 and 12 months after radiotherapy
Secondary Body Mass index (BMI) in kg/m^2 Baseline, 3, 6 and 12 months after radiotherapy
Secondary Functional Oral Intake Scale (FOIS) Baseline, 3, 6 and 12 months after radiotherapy
Secondary Overall duration of enteral nutrition 12 months after radiotherapy
Secondary Total treatment duration 12 months after radiotherapy
Secondary Number of treatment interruptions 12 months after radiotherapy
Secondary Number of patients with adverse events End of radiotherapy (an average of 2 months after baseline), 1, 3, 6 and 12 months after radiotherapy
Secondary Swallowing specific Quality of Life (SWAL-QOL) score Baseline, 3, 6 and 12 months after radiotherapy
Secondary Number of patients with aspiration and penetration determined by APS (Aspiration and Penetration Scale) scoring Baseline, 3, 6 and 12 months after radiotherapy
Secondary Rate of global survival 12 months after radiotherapy
Secondary Rate of survival without recurrence 12 months after radiotherapy
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