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

Cancer of Head and Neck Clinical Trial

— RORC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02892487
• Other study ID #: 35RC14_9786_RORC
• Status: Terminated
• Phase: N/A
• Start date: December 9, 2016
• Est. completion date: June 2021

Study information

• Verified date: November 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• 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: Terminated
• Enrollment: 183
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• 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

Related Conditions & MeSH terms

• Cancer of Head and Neck
• Head and Neck Neoplasms

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