Dysphagia Assessment After Swallowing Sparing RadioTherapy

NCT03448341 | Completed

• 1 other identifier: 1112
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer of Oropharynx; Cancer of Nasopharynx

Keywords

Radiotherapy; IMRT; Dysphagia; Oropharynx; Nasopharynx; FEES; VFS; Chemotherapy

Outcome Measures

Primary Outcomes (3)

• 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

  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

Secondary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Locally Advanced Oropharynx or Nasopharynx cancer, that can be treated with an exclusive chemo-radiotherapy.

You may qualify if:

• Histological diagnosis of squamous cell carcinoma or undifferentiated carcinoma of the otoiatric district
• Subsider of the primitive: (Nasopharynx Stage II and III); Oropharynx Stage III-IVA
• ECOG Status 0-2
• Chemiotherapy concomitant at radiotherapy (Cisplatin 100mg / m2 every 21 days or 40mg / m2 weekly)

You may not qualify if:

• Histological diagnosis different from squamous or undifferentiated cell carcinoma
• Subsider of the primitive different from Nasopharynx, Oropharynx
• Nasopharynx Stage IV; Oropharynx Stage IVB and C
• ECOG ≥3
• Prior induction chemotherapy
• Prior oncological surgery on the otoiatric district
• Prior radiation treatment on the otoiatric district
• Concomitant diseases that could modify the swallowing function (ex Amyotrophic Lateral Sclerosis or Multiple Sclerosis)
• A history of excessive use of benzodiazepines or similar (ex patients in psychiatric therapy) or eostroesophageal reflux resistant at medical therapy

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Pisana

Pisa, 56100, Italy

Location

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Nasopharyngeal Neoplasms; Deglutition Disorders

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: February 28, 2018
• Study Start: July 16, 2016
• Primary Completion: May 1, 2020
• Study Completion: January 31, 2022
• Last Updated: September 15, 2022

Record last verified: 2022-09

Locations

IT (1)