Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT03738657
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.
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:
NCT03738657
Study Brief:
Protocol Section:
NCT03738657