- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03738657
Gustatory Function Following Radiotherapy to the Head and Neck
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Lucinda Dr Gunn, Dr
- Phone Number: 4526 0207 352 8171
- Email: Lucinda.Gunn@rmh.nhs.uk
Study Contact Backup
- Name: Abigail Miss Temple
- Phone Number: 4020 0208 642 6011
- Email: Abigail.Temple@rmh.nhs.uk
Study Locations
-
-
-
London, United Kingdom, SW3 6JJ
- Recruiting
- Head and Neck Unit, Royal Marsden Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Screening
Olfactory screening
|
|
On Study
Taste testing
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
At 1 year
|
The association between RT dose to oral cavity structures and objective dysgeusia
Time Frame: At 1 year
|
Through use of using chemosensory testing
|
At 1 year
|
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.
|
At 1 year
|
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.
|
At 1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Chris Prof Nutting, Professor, Consultant
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCR4927
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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