Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-05 @ 6:20 PM
Study NCT ID:
NCT03738657
Status:
UNKNOWN
Last Update Posted:
2018-11-13
First Post:
2018-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gustatory Function Following Radiotherapy to the Head and Neck
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
Study Overview
Official Title:
Gustatory Function Following Radiotherapy to the Head and Neck
Status:
UNKNOWN
Status Verified Date:
2018-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: