Gustatory Function Following Radiotherapy to the Head and Neck
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Head and Neck Cancer
- Sponsor
- Royal Marsden NHS Foundation Trust
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- The association between radiotherapy dose and patient-reported dysgeusia at 6 months following RT or chemo-RT for HNC.
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
This study aims to collect data from patients with HNC undergoing RT or chemo-RT to correlate quantitative chemosensory gustatory function with * Detailed dosimetric data for critical structures relevant to perception of taste * Fungiform papillae density (FPD) * Use of concurrent platinum based therapy * Patient reported taste loss using The Taste and Smell Survey (TSS) \[14\] * Patient reported toxicity and overall QOL using University Washington Quality of Life Revised Version 4 (UW-QOL v4) \[15\]. * Clinician reported acute and late toxicity using NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4) \[16\] and Scale of Subjective Total Taste Acuity (STTA) \[17\]. * Weight (as a surrogate of nutritional status). This study hopes to demonstrate a dose dependent relationship for loss of taste and to develop a dose constraint for preservation of taste. In turn this will serve as a platform for further research to optimise the technical delivery of radiation either in the form of optimised IMRT or through the use of intensity modulated proton therapy (IMPT).
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
The association between radiotherapy dose and patient-reported dysgeusia at 6 months following RT or chemo-RT for HNC.
Time Frame: At 1 year
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.
Secondary Outcomes
- The association between patient-reported dysgeusia and percentage change in weight.(At 1 year)
- The association between RT dose to oral cavity structures and objective dysgeusia(At 1 year)
- The association between patient-reported dysgeusia and RT dose to the posterior third of the surface of the tongue, oral cavity, left and right parotid glands, left and right submandibular glands and the use of concomitant chemotherapy.(At 1 year)
- The association between either patient-reported dysguesia or objective dysgeusia(At 1 year)