An observational study in Head and Neck Cancer, sponsored by Royal Marsden NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-13.
Sponsored by Royal Marsden NHS Foundation Trust · Observational
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.
This study aims to collect data from patients with HNC undergoing RT or chemo-RT to correlate quantitative chemosensory gustatory function with
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).
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's planned enrollment of 110 is close to the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Royal Marsden NHS Foundation Trust is the lead sponsor of 262 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patients with radiological or clinical involvement of following nerves
Olfactory screening
Taste testing
Other: Olfactory screening · Other: Quantative Gustatory Testing using Taste Strips
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.
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.
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.
Time frame: At 1 year
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.
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).
Time frame: At 1 year
The association between RT dose to oral cavity structures and objective dysgeusia
Through use of using chemosensory testing
Time frame: At 1 year
The association between either patient-reported dysguesia or objective dysgeusia
Through using chemosensory testing and the use of concomitant chemotherapy.
Time frame: At 1 year
The association between patient-reported dysgeusia and percentage change in weight.
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.
Time frame: At 1 year
Plan to share: No
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Royal Marsden NHS Foundation Trust