The Characterisation of RT Caries.

NCT03397823 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 102

Last updated 2021-09-13

No results posted yet for this study

Summary

Overcoming limitations of previous studies, the following research project will assess the most significant acute and long-term complications of RT that affect HNC patients: oral mucositis, dry mouth feeling, taste alteration and carious lesion incidence, all of which negatively affect cancer treatment outcomes and the quality of life of cancer survivors. This project was developed with an aim to study any possible correlations / links between the oral sequelae of RT and the negative clinical outcomes listed, in order to help the development of clinical management protocols for HNC patients to mitigate the effect on care and patient comfort and its delivery in healthcare systems.

The project comprises of a longitudinal cohort study of HNC patients correlating biodata of biochemical salivary parameters, clinical outcomes and oral health status over a period up to 12 months post-RT, focusing on baseline pre-IMRT (T0), 6 months post-IMRT (T1) and up to 12 months post-IMRT treatments (T2). The ultimate goal is to identify possible predictive markers in the saliva at T0 to assist with evaluation of oral mucositis severity in individual HNC patients prior to start of treatment so that treatment can be adapted for such high-risk patients individually, to either prevent or minimise the severity of this consequence of RT.

Conditions

Sponsors & Collaborators

Principal Investigators

  • avijit banerjee, professor · King's College London

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-15
Primary Completion
2019-10-30
Completion
2019-10-30

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03397823 on ClinicalTrials.gov