The Characterisation of RT Caries.

NCT03397823 | Completed

• 1 other identifier: Radiotherapy caries
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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

Head and Neck Cancer; Radiotherapy Side Effect

Outcome Measures

Primary Outcomes (1)

• Effects of IMRT on saliva composition and potential associations with oral side effects

  integrated longitudinal study of HNC patients correlating biodata of biochemical parameters, clinical parameters and oral health status

  october 2019

Secondary Outcomes (3)

• IMRT effects on oral cavity

  2019

• IMRT effects on biochemical composition of saliva

  2019

• Association between selected salivary proteins and oral mucositis outcomes after IMRT

  2019

Study Arms (3)

head and neck cancer pre RT

head and neck cancer patients before and after RT

head and neck cancer treated

head and neck cancer patients treated with radiotherapy

control group

age gender matched subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Head and neck cancer patients treated with radiotherapy

You may qualify if:

• Head and Neck Cancer Patients Male or female Over the age of 18. Received radiation treatment for Head and Neck cancer

You may not qualify if:

• Subjects younger than 18. Patients unable to give consent. Patients with non-controlled systemic disease Distant metastases Patients who have been administered antibiotics in the previous 3 months Patients with Sjogren syndrome. Patients with Rheumatoid arthritis Neurological disorders (Parkinson's disease) Dehydration Sialoadenitis Sialolithiasis

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

kings college london, Guy's Hospital

London, SE1 9RT, United Kingdom

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Wounds and Injuries

Study Officials

• avijit banerjee, professor

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: January 12, 2018
• Study Start: February 15, 2017
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: September 13, 2021

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)