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

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Brief Title

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

Official Title

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

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.
    


Study Type

Interventional


Primary Outcome

Oral Mucositis Severity - WHO Scale

Secondary Outcome

 Level of Oral Pain (FACES Scale)

Condition

Oral Mucositis

Intervention

Oral Mucosa Deterging and Periodontal Debridement (OMDP)

Study Arms / Comparison Groups

 OMDP Group
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

19

Start Date

March 2014

Completion Date

September 2015

Primary Completion Date

September 2015

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).
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Patricia Corby, DDS, MS, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02608879

Organization ID

14-00082


Responsible Party

Sponsor

Study Sponsor

NYU Langone Health


Study Sponsor

Patricia Corby, DDS, MS, Principal Investigator, NYU Langone Medical Center


Verification Date

August 2020