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

NCT ID: NCT02608879

Last Updated: 2020-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-09-30

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.

Detailed Description

Oral mucositis (OM) is one of the most debilitating adverse effects in cancer patients treated with chemotherapy or radiation (RT). Currently, there are no effective therapies or prevention for mucositis, while several clinical studies have suggested that professional oral care could effectively reduce the severity of Radiation Therapy or chemotherapy-induced oral mucositis. Palliative treatment, rather than preventive or curative measures, remains the standard of care. Evidence-based guidelines do not provide consistent recommendations for the prevention, treatment and management of oral mucositis.

The investigators hypothesize that a monitored regimen of professional oral hygiene prevents harmful ecological shifts in the oral cavity, improve oral health and reduce the duration and severity of Oral Mucositis in cancer patients, consequently improving their overall quality of life during treatment. Moreover, the investigators hypothesize that the weekly oral hygiene regimen performed by an oral health professional is more effective in treating and preventing mucositis than current standard-of-care treatments.

The principal investigator of this project has developed a novel oral care regimen protocol for the treatment of oral mucositis. The "Oral Mucosa Deterging and Periodontal Debridement" (OMDP) protocol consists of a regimen of frequent professional oral prophylaxis including tooth cleaning, tooth polishing and flossing, and the debridement of the periodontium and deterging of the oral mucosa. This is an intervention that is implemented prior to and maintained throughout the entire cycle of the radiation or chemoradiation. Co-adjuvant treatments such as intense fluoride treatments, oral hygiene instructions and palliative mouth-rinses are also part of the protocol. The hypothesis is that repeated professional prophylaxis of the oral cavity would protect the healthy oral tissue against infection and inflammation often associated with severe cases of mucositis, and consequently reduces mucositis incidence and duration.

Participants in this study would attend approximately 9 study visits over the course of 16-18 weeks, depending on their specific cancer treatment plan. Study participants will be randomized to receive either the oral health protocol, which they will receive on a weekly basis, or standard of care oral hygiene instructions and tooth brushing, preformed on a bi-weekly basis.

Conditions

Oral Mucositis; Oral Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

OMDP Group

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.

Group Type: EXPERIMENTAL

Oral Mucosa Deterging and Periodontal Debridement (OMDP)

Intervention Type: 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.

Dental scaling, ultrasonic

Intervention Type: PROCEDURE

An ultrasonic dental scaler will be used to clean the teeth

Chlorhexidine

Intervention Type: OTHER

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

Control Group

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.

Group Type: OTHER

Standard of Care Oral Hygiene Instructions

Intervention Type: 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.

Interventions

Oral Mucosa Deterging and Periodontal Debridement (OMDP)

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.

Intervention Type: PROCEDURE

Standard of Care Oral Hygiene Instructions

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.

Intervention Type: PROCEDURE

Dental scaling, ultrasonic

An ultrasonic dental scaler will be used to clean the teeth

Intervention Type: PROCEDURE

Chlorhexidine

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

Intervention Type: OTHER

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia Corby, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Locations

NYU Langone Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

14-00082

Identifier Type: -

Identifier Source: org_study_id