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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
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

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.

Condition or disease Intervention/treatment
Head and Neck Cancer Other: Olfactory screening Other: Quantative Gustatory Testing using Taste Strips

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).

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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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

Group/Cohort Intervention/treatment
Screening
Olfactory screening
On Study
Taste testing
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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. The association between RT dose to oral cavity structures and objective dysgeusia [ Time Frame: At 1 year ]
    Through use of using chemosensory testing

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Contacts
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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

Locations
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United Kingdom
Head and Neck Unit, Royal Marsden Hospital Recruiting
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
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Principal Investigator: Chris Prof Nutting, Professor Consultant
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Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03738657    
Other Study ID Numbers: CCR4927
First Posted: November 13, 2018    Key Record Dates
Last Update Posted: November 13, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms