Status:
COMPLETED
Dysphagia Assessment After Swallowing Sparing RadioTherapy
Lead Sponsor:
Azienda Ospedaliero, Universitaria Pisana
Conditions:
Cancer of Oropharynx
Cancer of Nasopharynx
Eligibility:
All Genders
18-80 years
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 Evaluat...
Detailed Description
The aim of the study is to prospectively investigate the impact of radiochemotherapy on both the deglution-related quality of life (QoL) by means of MDADI questionnaire and the swallowing function by ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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)
- Exclusion criteria
- 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
Exclusion
Key Trial Info
Start Date :
July 16 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT03448341
Start Date
July 16 2016
End Date
January 31 2022
Last Update
September 15 2022
Active Locations (1)
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1
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56100