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

NCT02608879 | Completed Results

• 1 other identifier: 14-00082
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Mucositis; Oral Cancer

Keywords

proinflammatory cytokines; microbiome; radiation therapy

Outcome Measures

Primary Outcomes (2)

• Oral Mucositis Severity - WHO Scale

  OM severity will be assessed by the WHO Oral Mucositis Scale at each follow-up visit. The WHO Oral Mucositis Scale is a 5 point scale (0 to 4) with the following scoring system: 0=None 1. Soreness with erythema 2. Erythema, ulcers, can eat solids 3. Ulcers, liquid diet only 4. Alimentation not possible

  End of Radiation Treatment (approximately week 7)

• Oral Mucositis Severity - NCI Scale

  OM severity will be assessed by the NCI-CTCAE Scale (National Cancer Institute - Common Toxicity Criteria and Grading of Adverse Events) at each follow-up visit. The NCI-CTCAE is a 5 point scale (1-5) with the following grading system: 1. Erythema of the mucosa 2. Patchy ulcerations or pseudomembranes 3. Confluent ulcerations or pseudomembranes; bleeding with minor trauma 4. Tissue necrosis; significant spontaneous bleeding; life-threatening consequences 5. Death

  End of Radiation Treatment (approximately week 7)

Secondary Outcomes (7)

• Level of Oral Pain (FACES Scale)

  End of Radiation Treatment (approximately week 7)

• Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Right Side) From Baseline to Onset of Oral Mucositis

  Baseline to Onset of Oral Mucositis

• Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Left Side) From Baseline to Onset of Oral Mucositis

  Baseline to Onset of Oral Mucositis

• Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Right Side) From Baseline to Onset of Oral Mucositis

  Baseline to Onset of Oral Mucositis

• Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Left Side) From Baseline to Onset of Oral Mucositis

  Baseline to Onset of Oral Mucositis

Study Arms (2)

OMDP Group

EXPERIMENTAL

Subjects randomized to this group will attend weekly visits and receive a full dental cleaning, as well as have their gums/tongue cleaned by a dental professional. Subjects will also receive standard of care oral hygiene instructions.

Procedure: Oral Mucosa Deterging and Periodontal Debridement (OMDP); Procedure: Dental scaling, ultrasonic; Other: Chlorhexidine

Control Group

OTHER

Subjects assigned to the control group will receive standard of care oral health instructions and will come for bi-weekly treatment visits where they will have their teeth cleaned (brushed) by a dental professional.

Procedure: Standard of Care Oral Hygiene Instructions

Interventions

Oral Mucosa Deterging and Periodontal Debridement (OMDP) PROCEDURE

OMDP consists of a regimen of frequent professional oral prophylaxis including tooth cleaning, tooth polishing and flossing, and the cleaning of the periodontum and oral mucosa. This is an intervention that is implemented prior to and maintained throughout the entire cycle of the radiation or chemoradiation.

OMDP Group

Standard of Care Oral Hygiene Instructions PROCEDURE

Subjects assigned to this intervention will receive standard of care oral hygiene instructions, including in-person instruction and materials to reference at home. Subjects will also have their teeth brushed and flossed bi-weekly by a dental professional.

Control Group

Dental scaling, ultrasonic PROCEDURE

An ultrasonic dental scaler will be used to clean the teeth

OMDP Group

Chlorhexidine OTHER

Non-alcoholic chlorhexidine will be used as part of the OMDP protocol

OMDP Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Stomatitis; Mouth Neoplasms

Interventions

Periodontal Debridement; Dental Scaling; High-Energy Shock Waves; Chlorhexidine

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Dental Prophylaxis; Periodontics; Dentistry; Preventive Dentistry; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Patricia Corby, Principal Investigator
• Organization: NYU Langone Medical Center

patricia.corby@nyumc.org

646-501-2615

Study Officials

• Patricia Corby, DDS, MS

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: November 20, 2015
• Study Start: March 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 28, 2020
• Results First Posted: August 28, 2020

Record last verified: 2020-08

Locations

US (1)