Evaluation of an Active Swallowing Rehabilitation on Quality of Life of Patients Treated by Radiotherapy for Head and Neck Cancer (RORC)
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|ClinicalTrials.gov Identifier: NCT02892487|
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : October 17, 2019
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).
|Condition or disease||Intervention/treatment||Phase|
|Cancer of Head and Neck||Other: Swallowing therapy||Not Applicable|
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.
- 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.
- 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 (Clinical Trial)|
|Estimated Enrollment :||420 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluation of an Active Swallowing Rehabilitation on Quality of Life of Patients Treated by Radiotherapy for Head and Neck Cancer|
|Actual Study Start Date :||December 9, 2016|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||January 2022|
|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.
|No Intervention: Usual care|
- 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 [ Time Frame: 6 months after radiotherapy ]HNSW = Head and Neck Swallowing Questionnaire
- EORTC QLQ-C30 score [ Time Frame: Baseline, 3, 6 and 12 months after radiotherapy ]EORTC QLQ = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire
- EORTC H&N35 score [ Time Frame: Baseline, 3, 6 and 12 months after radiotherapy ]EORTC H&N = European Organisation for Research and Treatment of Cancer Head and Neck questionnaire
- MFI-20 score [ Time Frame: Baseline, 3, 6 and 12 months after radiotherapy ]MFI = Multidimensional Fatigue Inventory
- Body Mass index (BMI) [ Time Frame: Baseline, 3, 6 and 12 months after radiotherapy ]in kg/m^2
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892487
|Contact: Claire FOUGEROU||+33 (0)2 99 28 37 firstname.lastname@example.org|
|Principal Investigator:||Franck JEGOUX||Rennes University Hospital|