Gustatory Function Following Radiotherapy to the Head and Neck

NCT ID: NCT03738657

Last Updated: 2018-11-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-29
• Study Completion Date: 2020-03-31

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).

Conditions

Head and Neck Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Screening

Olfactory screening

No interventions assigned to this group

On Study

Taste testing

Olfactory screening

Intervention Type: OTHER

Therefore prior to gustatory testing, patients will be screened and assessed as having either normal or abnormal olfactory function using the Sniffin' Sticks (Burghart; Wedel, Germany). The test consists of 12 odour pens which represent every-day odours (peppermint, fish, coffee, banana, orange, rose, lemon, pineapple, cinnamon, cloves, leather and liquorice). Patients are presented with an odour and select the perceived smell using a multiple-forced-choice method.

Quantative Gustatory Testing using Taste Strips

Intervention Type: OTHER

Following screening for olfactory function, whole mouth gustatory function will be assessed using validated taste strips (Burghart; Wedel, Germany). Filter paper test strips are impregnated at one end with 2cm2 of either sweet, sour, salty or bitter taste solutions in four concentrations. In a pseudo-randomised sequence, individual strips will be placed on the tongue and patients will be asked to close their mouth in order to assess whole mouth function. Through a forced-choice procedure patients will be asked to identify the taste stimuli. Scores for individual taste qualities will range from 0-4 and an overall taste score will range from 0-16.

Patients will rinse their mouth with tap water prior the application of each taste strip.

Interventions

Olfactory screening

Therefore prior to gustatory testing, patients will be screened and assessed as having either normal or abnormal olfactory function using the Sniffin' Sticks (Burghart; Wedel, Germany). The test consists of 12 odour pens which represent every-day odours (peppermint, fish, coffee, banana, orange, rose, lemon, pineapple, cinnamon, cloves, leather and liquorice). Patients are presented with an odour and select the perceived smell using a multiple-forced-choice method.

Intervention Type: OTHER

Quantative Gustatory Testing using Taste Strips

Following screening for olfactory function, whole mouth gustatory function will be assessed using validated taste strips (Burghart; Wedel, Germany). Filter paper test strips are impregnated at one end with 2cm2 of either sweet, sour, salty or bitter taste solutions in four concentrations. In a pseudo-randomised sequence, individual strips will be placed on the tongue and patients will be asked to close their mouth in order to assess whole mouth function. Through a forced-choice procedure patients will be asked to identify the taste stimuli. Scores for individual taste qualities will range from 0-4 and an overall taste score will range from 0-16.

Patients will rinse their mouth with tap water prior the application of each taste strip.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chris Prof Nutting, Professor

Role: PRINCIPAL_INVESTIGATOR

Consultant

Locations

Head and Neck Unit, Royal Marsden Hospital

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Lucinda Dr Gunn, Dr

Role: CONTACT

Lucinda.Gunn@rmh.nhs.uk

0207 352 8171 ext. 4526

Abigail Miss Temple

Role: CONTACT

Abigail.Temple@rmh.nhs.uk

0208 642 6011 ext. 4020

Other Identifiers

CCR4927

Identifier Type: -

Identifier Source: org_study_id