Gustatory Function Following Radiotherapy to the Head and Neck

NCT03738657 | Unknown

• 1 other identifier: CCR4927
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• The association between radiotherapy dose and patient-reported dysgeusia at 6 months following RT or chemo-RT for HNC.

  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.

  At 1 year

Secondary Outcomes (4)

• 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 RT dose to oral cavity structures and objective dysgeusia

  At 1 year

• The association between either patient-reported dysguesia or objective dysgeusia

  At 1 year

• The association between patient-reported dysgeusia and percentage change in weight.

  At 1 year

Study Arms (2)

Screening

Olfactory screening

On Study

Taste testing

Other: Olfactory screening; Other: Quantative Gustatory Testing using Taste Strips

Interventions

Olfactory screening 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.

On Study

Quantative Gustatory Testing using Taste Strips 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.

On Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

Head and Neck Unit, Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Chris Prof Nutting, Professor

  Consultant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucinda Dr Gunn, Dr

CONTACT

0207 352 8171; Lucinda.Gunn@rmh.nhs.uk

Abigail Miss Temple

CONTACT

0208 642 6011; Abigail.Temple@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: November 13, 2018
• Study Start: August 29, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: November 13, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)