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NCT03448341: DASRT

Dysphagia Assessment After Swallowing Sparing RadioTherapy

Completed Last updated 15 September 2022
What this trial tests

trial in Cancer of Oropharynx in 74 participants. Completed in 31 January 2022.

Timeline
16 July 2016
Primary endpoint
1 May 2020
31 January 2022

Quick facts

Lead sponsorAzienda Ospedaliero, Universitaria Pisana
StatusCompleted
Study typeOBSERVATIONAL
Enrollment74
Start date16 July 2016
Primary completion1 May 2020
Estimated completion31 January 2022
Sites1 location across Italy

Conditions studied

Sponsor

Azienda Ospedaliero, Universitaria Pisana — full company profile →

Who can join

Adults 18 to 80, any sex, with Cancer of Oropharynx or Cancer of Nasopharynx. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Patient-Reported Outcomes After Swallowing (SWOARs)-Sparing IMRT in Head and Neck Cancers: Primary Results from a Prospective Study Endorsed by the Head and Neck Study Group (HNSG) of the Italian Association of Radiotherapy and Clinical Oncology (AIRO).
    Ursino S, Calistri E, De Felice F, Bonomo P, et al · · 2023 · cited 6× · PMID 35587295 · DOI 10.1007/s00455-022-10434-4

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Other Azienda Ospedaliero, Universitaria Pisana trials

Trials by the same sponsor.

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Data sources for this page

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