An interventional study of Swallowing therapy in Cancer of Head and Neck, sponsored by Rennes University Hospital. Terminated at 21 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Rennes University Hospital · Not applicable, Interventional, and Supportive care
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).
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 183 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
Time frame: 6 months after radiotherapy
EORTC QLQ-C30 score
EORTC QLQ = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire
Time frame: 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
Time frame: Baseline, 3, 6 and 12 months after radiotherapy
MFI-20 score
MFI = Multidimensional Fatigue Inventory
Time frame: Baseline, 3, 6 and 12 months after radiotherapy
Body Mass index (BMI)
in kg/m\^2
Time frame: Baseline, 3, 6 and 12 months after radiotherapy
Functional Oral Intake Scale (FOIS)
Time frame: Baseline, 3, 6 and 12 months after radiotherapy
Overall duration of enteral nutrition
Time frame: 12 months after radiotherapy
Total treatment duration
Time frame: 12 months after radiotherapy
Number of treatment interruptions
Time frame: 12 months after radiotherapy
Number of patients with adverse events
Time frame: 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
Time frame: Baseline, 3, 6 and 12 months after radiotherapy
Number of patients with aspiration and penetration determined by APS (Aspiration and Penetration Scale) scoring
Time frame: Baseline, 3, 6 and 12 months after radiotherapy
Rate of global survival
Time frame: 12 months after radiotherapy
Rate of survival without recurrence
Time frame: 12 months after radiotherapy
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Rennes University Hospital