Oral Care Protocol for the Management of Chemotherapy and Radiation Therapy-Induced Oral Mucositis

Completed · Not applicable

Conditions studied: Oral Mucositis, Oral Cancer

In brief

The purpose of this study is to determine the effects of a novel oral care protocol on the severity and pain of oral mucositis in patients receiving radiation and/or chemotherapy for head and neck cancers. The secondary objectives are to characterize the microbiome associated with oral mucositis, measure salivary proinflammatory cytokines, and evaluate other clinical indicators of the intervention. Participants will be enrolled prior to beginning radiation and/or chemotherapy, and will be randomized to receive either the oral health protocol or standard of care oral hygiene.

Key facts

Study ID

NCT02608879

Run by

NYU Langone Health

People needed

19

Starts

2014-03-01

Expected to finish

2015-09-01

Last updated by the study team

2020-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patient aged 18 years or older;
• Patients must sign an informed consent before data collection, screening, or initiation of study procedures;
• Patients who are scheduled to undergo radiation or chemoradiation treatment for head/neck cancer;
• Patients who have a minimum of 6 natural teeth at the time of enrollment.

You may not qualify if…

• Female patients who are pregnant or lactating at the baseline/screening visit;
• Patient participating in another biomedical/oral health research study that would interfere with participating in this study;
• Patient deprived of freedom, under supervision or guardianship;
• Patient unable to attend to scheduled medical monitoring due to geographical, social or mental reasons;
• Immune compromised or other serious medical conditions, regardless of whether the condition is controlled or not;
• Patient who requires pre-medication prior to dental treatment;
• Any patient, in the opinion of the Investigator, who is unable or unlikely to comply fully with the study requirements or procedures for any reason (e.g. major surgical resection of intra-oral structures which would prevent oral care intervention, edentulous, severe periodontal disease, etc).

Where it is running

• NYU Langone Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.