Clinical trial · Observational
Dysphagia Assessment After Swallowing Sparing RadioTherapy
Clinical and Instrumental Evaluation of Late Dysphagia in Naso and Oropharynx Cancer After Swallowing-organs (SWOARs)-Sparing Chemo-IMRT
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Nasopharynx | Nasopharyngeal Carcinoma | ALIAS | 0.90 |
| Cancer of Oropharynx | Oropharyngeal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- To assess the changes of deglutition-related quality of life by means of MDADI questionnaire from before to after radiochemotherapy
- timeFrame
- Baseline, 6 and 12 months treatment
- description
- 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.
- measure
- To assess the changes of deglutition function by means of Fiberoptic Endoscopic Evaluation of Swallowing (FEES) from before to after radiochemotherapy
- timeFrame
- Before, 6 and 12 months after treatment
- description
- 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
- measure
- To assess the changes of deglutition function by means of Videofluoroscopy (VFS) from before to after radiochemotherapy
- timeFrame
- Before, 6 and 12 months after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria 1. Histological diagnosis of squamous cell carcinoma or undifferentiated carcinoma of the otoiatric district 2. Subsider of the primitive: (Nasopharynx Stage II and III); Oropharynx Stage III-IVA 3. ECOG Status 0-2 4. Chemiotherapy concomitant at radiotherapy (Cisplatin 100mg / m2 every 21 days or 40mg / m2 weekly) Exclusion criteria 1. Histological diagnosis different from squamous or undifferentiated cell carcinoma 2. Subsider of the primitive different from Nasopharynx, Oropharynx 3. Nasopharynx Stage IV; Oropharynx Stage IVB and C 4. ECOG ≥3 5. Prior induction chemotherapy 6. Prior oncological surgery on the otoiatric district 7. Prior radiation treatment on the otoiatric district 8. Concomitant diseases that could modify the swallowing function (ex Amyotrophic Lateral Sclerosis or Multiple Sclerosis) 9. A history of excessive use of benzodiazepines or similar (ex patients in psychiatric therapy) or eostroesophageal reflux resistant at medical therapy
References
Publications (0)
Data not yet available