NCT03448341|Completed
Dysphagia Assessment After Swallowing Sparing RadioTherapy
DASRT
Clinical and Instrumental Evaluation of Late Dysphagia in Naso and Oropharynx Cancer After Swallowing-organs (SWOARs)-Sparing Chemo-IMRT
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DASRT
Clinical and Instrumental Evaluation of Late Dysphagia in Naso and Oropharynx Cancer After Swallowing-organs (SWOARs)-Sparing Chemo-IMRT
Sponsor study identifier
observational
74
1 country
1
Study Start
July 16, 2016
Actual (reported)Primary Completion
May 1, 2020
Actual (reported)Study Completion
January 31, 2022
Actual (reported)To prospectively assess post-radiation late dysphagia by using MDADI questionnaire (deglutition-related quality of life) and objective instrumental assessment by means of Fiberoptic Endoscopic Evaluation of Swallowing (FEES) and Videofluoroscopy (VFS) in patients affected by nasopharynx and oropharynx cancers candidates to radiochemotherapy. Radiotherapy is delivered by using Intensity and Modulated Technique (IMRT) with a planning dose optimization to the swallowing related structures (SWOARs-sparing IMRT). The primary aim is to assess the variations of MDADI, FEES and VFS from baseline to 6 and 12 months after treatment. The secondary aim is to correlate clinical and instrumental results as well as radiation dose received by the different swallowing related structures (SWOARs) to the variations of clinical (MDADI) and instrumental (FEES and VFS) scores.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 16, 2016
Actual (reported)February 22, 2018
Actual (reported)February 28, 2018
Actual (reported)May 1, 2020
Actual (reported)January 31, 2022
Actual (reported)To assess the changes of deglutition-related quality of life by means of MDADI questionnaire from before to after radiochemotherapy
All patients will be evaluated by using MDADI questionnaire at baseline and at 6 and 12 months after radiochemotherapy. The variations of MDADI questionnaire scores from before to after treatment will be analysed.
Baseline, 6 and 12 months treatment
To assess the changes of deglutition function by means of Fiberoptic Endoscopic Evaluation of Swallowing (FEES) from before to after radiochemotherapy
All patients will be evaluated by using FEES at baseline and at 6 and 12 months after radiochemotherapy. The variations of FEES scores from before to after treatment will be analysed
Before, 6 and 12 months after treatment
To assess the changes of deglutition function by means of Videofluoroscopy (VFS) from before to after radiochemotherapy
Patients with Locally Advanced Oropharynx or Nasopharynx cancer, that can be treated with an exclusive chemo-radiotherapy.
Azienda Ospedaliero Universitaria Pisana
Pisa, 56100, Italy
74 participants (actual enrollment reported by the registry).
First Submitted
February 22, 2018
First Posted
February 28, 2018
Study Start
July 16, 2016
Actual (reported)Recombinant Human Granulocyte Macrophage Colony Stimulating Factor(rhGM-CSF) Treating Oral Mucositis
All patients will be evaluated by using VFS at baseline and at 6 and 12 months after radiochemotherapy. The variations of VFS scores from before to after treatment will be analysed
Before, 6 and 12 months after treatment
To correlate MDADI score (deglutition-related quality of life) changes with FEES and VFS score (deglutition function) changes from before to after treatment
Before, 6 and 12 months after treatment
To correlate radiation dose features received by the different swallowing related structures (SWOARs) to the changes of MDADI, FEES and VFS scores from before to after treatment by using a Machine Learning Methodology
At baseline and at 6 and 12 months
Contact the study team to confirm eligibility.
Primary Completion
May 1, 2020
Actual (reported)Study Completion
January 31, 2022
Actual (reported)Last Updated
September 15, 2022
Record last verified: 2022-09
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Source: ClinicalTrials.gov.
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