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

NCT02892487 | Terminated

• 1 other identifier: 35RC14_9786_RORC
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 21

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).

Conditions

Cancer of Head and Neck

Keywords

Quality of life; Radiotherapy; Dysphagia; Oral cavity; Oropharynx; Hypopharynx; Larynx; Swallowing rehabilitation; Toxicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• EORTC QLQ-C30 score

  Baseline, 3, 6 and 12 months after radiotherapy

• EORTC H&N35 score

  Baseline, 3, 6 and 12 months after radiotherapy

• MFI-20 score

  Baseline, 3, 6 and 12 months after radiotherapy

• Body Mass index (BMI)

  Baseline, 3, 6 and 12 months after radiotherapy

• Functional Oral Intake Scale (FOIS)

  Baseline, 3, 6 and 12 months after radiotherapy

Study Arms (2)

Early active swallowing therapy

EXPERIMENTAL

Other: Swallowing therapy

Usual care

NO INTERVENTION

Interventions

Swallowing therapy 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.

Early active swallowing therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Written informed consent
• Patients with health insurance

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (21)

Brest University Hospital

Brest, France

Location

Caen University Hospital

Caen, France

Location

Centre François Baclesse

Caen, France

Location

Clermont-Ferrand University Hospital

Clermont-Ferrand, France

Location

Le Mans Hospital

Le Mans, France

Location

Lille University Hospital

Lille, France

Location

Bretagne Sud Hospital

Lorient, France

Location

Lyon University Hospital

Lyon, France

Location

Marseille University Hospital

Marseille, France

Location

Centre Alexis Vautrin

Nancy, France

Location

Nantes University Hospital

Nantes, France

Location

Centre Antoine Lacassagne

Nice, France

Location

Tenon Hospital

Paris, France

Location

Poitiers University Hospital

Poitiers, France

Location

Clinique La Sagesse

Rennes, France

Location

Rennes University Hospital

Rennes, France

Location

Strasbourg University Hospital

Strasbourg, France

Location

Toulouse University Hospital

Toulouse, France

Location

Tours University Hospital

Tours, France

Location

Bretagne Atlantique Hospital

Vannes, France

Location

Institut Gustave Roussy

Villejuif, France

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Deglutition Disorders; Laryngeal Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Respiratory Tract Diseases

Study Officials

• Franck JEGOUX

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 8, 2016
• Study Start: December 9, 2016
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (21)