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

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).

Study Overview

• Status: Terminated
• Conditions: Cancer of Head and Neck
• Intervention / Treatment: Other: Swallowing therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France
    • Brest University Hospital
  • Caen, France
    • Centre Francois Baclesse
  • Caen, France
    • Caen University Hospital
  • Clermont-Ferrand, France
    • Clermont-Ferrand University Hospital
  • Le Mans, France
    • Le Mans Hospital
  • Lille, France
    • Lille University Hospital
  • Lorient, France
    • Bretagne Sud Hospital
  • Lyon, France
    • Lyon University Hospital
  • Marseille, France
    • Marseille University hospital
  • Nancy, France
    • Centre Alexis Vautrin
  • Nantes, France
    • Nantes University Hospital
  • Nice, France
    • Centre Antoine Lacassagne
  • Paris, France
    • Tenon Hospital
  • Poitiers, France
    • Poitiers University Hospital
  • Rennes, France
    • Rennes University Hospital
  • Rennes, France
    • Clinique La sagesse
  • Strasbourg, France
    • Strasbourg University Hospital
  • Toulouse, France
    • Toulouse University Hospital
  • Tours, France
    • Tours University Hospital
  • Vannes, France
    • Bretagne Atlantique Hospital
  • Villejuif, France
    • Institut Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care
Experimental: Early active swallowing therapy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
MFI-20 score	MFI = Multidimensional Fatigue Inventory	Baseline, 3, 6 and 12 months after radiotherapy
Body Mass index (BMI)	in kg/m^2	Baseline, 3, 6 and 12 months after radiotherapy
Functional Oral Intake Scale (FOIS)		Baseline, 3, 6 and 12 months after radiotherapy
Overall duration of enteral nutrition		12 months after radiotherapy
Total treatment duration		12 months after radiotherapy
Number of treatment interruptions		12 months after radiotherapy
Number of patients with adverse events		End of radiotherapy (an average of 2 months after baseline), 1, 3, 6 and 12 months after radiotherapy
Swallowing specific Quality of Life (SWAL-QOL) score		Baseline, 3, 6 and 12 months after radiotherapy
Number of patients with aspiration and penetration determined by APS (Aspiration and Penetration Scale) scoring		Baseline, 3, 6 and 12 months after radiotherapy
Rate of global survival		12 months after radiotherapy
Rate of survival without recurrence		12 months after radiotherapy

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Franck JEGOUX, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2016
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (Estimated): September 8, 2016

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Quality of life; Dysphagia; Radiotherapy; Toxicity; Larynx; Hypopharynx; Oropharynx; Oral cavity; Swallowing rehabilitation
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 35RC14_9786_RORC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO