Gustatory Function Following Radiotherapy to the Head and Neck
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|ClinicalTrials.gov Identifier: NCT03738657|
Recruitment Status : Recruiting
First Posted : November 13, 2018
Last Update Posted : November 13, 2018
|Condition or disease||Intervention/treatment|
|Head and Neck Cancer||Other: Olfactory screening Other: Quantative Gustatory Testing using Taste Strips|
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) 
- Patient reported toxicity and overall QOL using University Washington Quality of Life Revised Version 4 (UW-QOL v4) .
- Clinician reported acute and late toxicity using NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4)  and Scale of Subjective Total Taste Acuity (STTA) .
- 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 Type :||Observational|
|Estimated Enrollment :||110 participants|
|Official Title:||Gustatory Function Following Radiotherapy to the Head and Neck|
|Actual Study Start Date :||August 29, 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
Other: 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.
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.
- 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.
- 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. [ Time Frame: 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 RT dose to oral cavity structures and objective dysgeusia [ Time Frame: At 1 year ]Through use of using chemosensory testing
- The association between either patient-reported dysguesia or objective dysgeusia [ Time Frame: At 1 year ]Through using chemosensory testing and the use of concomitant chemotherapy.
- The association between patient-reported dysgeusia and percentage change in weight. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03738657
|Contact: Lucinda Dr Gunn, Dr||0207 352 8171 ext 4526||Lucinda.Gunn@rmh.nhs.uk|
|Contact: Abigail Miss Temple||0208 642 6011 ext 4020||Abigail.Temple@rmh.nhs.uk|
|Head and Neck Unit, Royal Marsden Hospital||Recruiting|
|London, United Kingdom, SW3 6JJ|
|Principal Investigator:||Chris Prof Nutting, Professor||Consultant|