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

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 19
• Participant gender: Both

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine
• Treatments: Chlorhexidine; Chlorhexidine gluconate
• Last Updated: 2016-03-02

Criteria

Inclusion Criteria:

1. Male and female patient aged 18 years or older;

2. Patients must sign an informed consent before data collection, screening, or initiation of study procedures;

3. Patients who are scheduled to undergo radiation or chemoradiation treatment for head/neck cancer;

4. Patients who have a minimum of 6 natural teeth at the time of enrollment.

Exclusion Criteria:

1. Female patients who are pregnant or lactating at the baseline/screening visit;

2. Patient participating in another biomedical/oral health research study that would interfere with participating in this study;

3. Patient deprived of freedom, under supervision or guardianship;

4. Patient unable to attend to scheduled medical monitoring due to geographical, social or mental reasons;

5. Immune compromised or other serious medical conditions, regardless of whether the condition is controlled or not;

6. Patient who requires pre-medication prior to dental treatment;

7. 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).