Clinical trial NCT03738657: Gustatory Function Following Radiotherapy to the Head and Neck
Official title: Gustatory Function Following Radiotherapy to the Head and Neck
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with H\&N cancer staged at T1-T4 disease and N0-N3 disease attending RMH who have consented to treatment with curative intent using RT or chemo-RT.

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).

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

Primary outcomes:
measure: The association between radiotherapy dose and patient-reported dysgeusia at 6 months following RT or chemo-RT for HNC.
timeFrame: At 1 year
Secondary outcomes:
measure: 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.
timeFrame: At 1 year
measure: The association between RT dose to oral cavity structures and objective dysgeusia
timeFrame: At 1 year
measure: The association between either patient-reported dysguesia or objective dysgeusia
timeFrame: At 1 year
measure: The association between patient-reported dysgeusia and percentage change in weight.
timeFrame: At 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Head and Neck Unit, Royal Marsden Hospital
Study officials:
affiliation: Consultant
name: Chris Prof Nutting, Professor
role: PRINCIPAL_INVESTIGATOR
References: