Clinical trial NCT02892487: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer of Head and Neck
Keywords: Quality of life
Radiotherapy
Dysphagia
Oral cavity
Oropharynx
Hypopharynx
Larynx
Swallowing rehabilitation
Toxicity
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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

Primary outcomes:
measure: 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
timeFrame: 6 months after radiotherapy
Secondary outcomes:
measure: EORTC QLQ-C30 score
timeFrame: Baseline, 3, 6 and 12 months after radiotherapy
measure: EORTC H&N35 score
timeFrame: Baseline, 3, 6 and 12 months after radiotherapy
measure: MFI-20 score
timeFrame: Baseline, 3, 6 and 12 months after radiotherapy
measure: Body Mass index (BMI)
timeFrame: Baseline, 3, 6 and 12 months after radiotherapy
measure: Functional Oral Intake Scale (FOIS)
timeFrame: Baseline, 3, 6 and 12 months after radiotherapy
measure: Overall duration of enteral nutrition
timeFrame: 12 months after radiotherapy
measure: Total treatment duration
timeFrame: 12 months after radiotherapy
measure: Number of treatment interruptions
timeFrame: 12 months after radiotherapy
measure: Number of patients with adverse events
timeFrame: End of radiotherapy (an average of 2 months after baseline), 1, 3, 6 and 12 months after radiotherapy
measure: Swallowing specific Quality of Life (SWAL-QOL) score
timeFrame: Baseline, 3, 6 and 12 months after radiotherapy
measure: Number of patients with aspiration and penetration determined by APS (Aspiration and Penetration Scale) scoring
timeFrame: Baseline, 3, 6 and 12 months after radiotherapy
measure: Rate of global survival
timeFrame: 12 months after radiotherapy
measure: Rate of survival without recurrence
timeFrame: 12 months after radiotherapy
Other outcomes:
Locations:
city: Brest
country: France
facility: Brest University Hospital
city: Caen
country: France
facility: Caen University Hospital
city: Caen
country: France
facility: Centre François Baclesse
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
city: Le Mans
country: France
facility: Le Mans Hospital
city: Lille
country: France
facility: Lille University Hospital
city: Lorient
country: France
facility: Bretagne Sud Hospital
city: Lyon
country: France
facility: Lyon University Hospital
city: Marseille
country: France
facility: Marseille University Hospital
city: Nancy
country: France
facility: Centre Alexis Vautrin
city: Nantes
country: France
facility: Nantes University Hospital
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Tenon Hospital
city: Poitiers
country: France
facility: Poitiers University Hospital
city: Rennes
country: France
facility: Clinique La Sagesse
city: Rennes
country: France
facility: Rennes University Hospital
city: Strasbourg
country: France
facility: Strasbourg University Hospital
city: Toulouse
country: France
facility: Toulouse University Hospital
city: Tours
country: France
facility: Tours University Hospital
city: Vannes
country: France
facility: Bretagne Atlantique Hospital
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Rennes University Hospital
name: Franck JEGOUX
role: PRINCIPAL_INVESTIGATOR
References: