Gustatory Function Following Radiotherapy to the Head and Neck

• Conditions: Head and Neck Cancer
• Interventions: Other: Olfactory screening; Other: Quantative Gustatory Testing using Taste Strips

• Registration Number: NCT03738657
• Lead Sponsor: Royal Marsden NHS Foundation Trust

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).

Study Timeline

• Study First Submitted: 2018-08-28
• Study Start: 2018-08-29
• Status Verified: 2018-11
• Study First Submitted QC: 2018-11-08
• Last Update Submitted: 2018-11-08
• Study First Posted: 2018-11-13
• Last Update Posted: 2018-11-13
• Primary Completion: 2020-03
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
On Study	Olfactory screening	Taste testing
On Study	Quantative Gustatory Testing using Taste Strips	Taste testing

Primary Outcome Measures

Name	Time	Method
The association between radiotherapy dose and patient-reported dysgeusia at 6 months following RT or chemo-RT for HNC.	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 Outcome Measures

Name	Time	Method
The association between patient-reported dysgeusia and percentage change in weight.	At 1 year	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 as above.
The association between RT dose to oral cavity structures and objective dysgeusia	At 1 year	Through use of using chemosensory testing
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	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 as above. dose volume histogram data will generate mean dose to oral cavity structures (including posterior third of tongue, anterior two thirds of the tongue, whole oral cavity, parotid glands, submandibular glands).
The association between either patient-reported dysguesia or objective dysgeusia	At 1 year	Through using chemosensory testing and the use of concomitant chemotherapy.

Trial Locations

Locations (1)

Head and Neck Unit, Royal Marsden Hospital; 🇬🇧 London, United Kingdom