Clinical trial · Observational
Gustatory Function Following Radiotherapy to the Head and Neck
NCT03738657CI-TRIAL-00035741unknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of this study is to assess the effect of RT or chemo-RT on chemosensory gustatory function in patients with HNC. By using detailed dosimetric data derived from the RT planning system, we will be able to calculate mean radiation doses to important structures including the anterior and posterior tongue, oral cavity, parotid and submandibular salivary glands, and correlate them with both qualitative and quantitative data for dysgeusia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Olfactory screening | Other | — | UNRESOLVED |
| Quantative Gustatory Testing using Taste Strips | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Screening
- description
- Olfactory screening
- label
- On Study
- description
- Taste testing
- interventionNames
- Other: Olfactory screening
- Other: Quantative Gustatory Testing using Taste Strips
Primary outcomes (1)
- measure
- The association between radiotherapy dose and patient-reported dysgeusia at 6 months following RT or chemo-RT for HNC.
- timeFrame
- At 1 year
- description
- Compare the mean dose delivered to the anterior two thirds of the surface of the tongue for those patients who report clinically significant dysgeusia at 6 months, with those who report clinically insignificant dysgeusia. For the purposes of the primary objective, mean dose (Gy) to the anterior two thirds of the tongue will be used. Patient-reported dysgeusia will be assessed using the Taste and Smell Survey (Q13) and patient results will be dichotomised into clinically significant and clinically insignificant loss of taste.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>/= 18 years * Undergoing unilateral or bilateral RT or concurrent chemo-RT to the head and neck - region using either a conformal or IMRT planning technique or * No restrictions on tumour sub-site * No restriction on tumour histology * No restrictions on radiotherapy dose and fractionation * For entry into the cross-sectional cohort; patients 12 months post completion of unilateral or bilateral RT or concurrent chemo-RT to the head and neck region using either a conformal or IMRT planning technique. Exclusion Criteria: * Patients with pre-existing olfactory or gustatory disorders either self-reported or through objective taste function testing. * Patients with radiological or clinical involvement of following nerves * facial nerve * chorda tympani * glossopharyngeal nerve * lingual nerve * greater petrosal nerve * geniculate ganglion * Patients who have undergone a total or partial glossectomy
References
Publications (0)
Data not yet available
No reference posted for this study.