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Trial record 42 of 6995 for:    Oral Cancer | ( Map: United States )

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

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ClinicalTrials.gov Identifier: NCT02608879
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Oral Mucositis Oral Cancer Procedure: Oral Mucosa Deterging and Periodontal Debridement (OMDP) Procedure: Standard of Care Oral Hygiene Instructions Device: Dental scaling, ultrasonic Drug: Chlorhexidine Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Care Protocol for the Management of Chemotherapy and Radiation Therapy-Induced Oral Mucositis
Study Start Date : March 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Experimental: 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.
Procedure: 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.

Device: Dental scaling, ultrasonic
An ultrasonic dental scaler will be used to clean the teeth

Drug: Chlorhexidine
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.
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.




Primary Outcome Measures :
  1. Oral Mucositis Severity - WHO Scale [ Time Frame: 16 weeks ]
    OM severity will be assessed by the WHO Oral Mucositis Scale at each follow-up visit.

  2. Oral Mucositis Severity - NCI Scale [ Time Frame: 16 weeks ]
    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.


Secondary Outcome Measures :
  1. Distinctiveness of oral microbial species [ Time Frame: 16 weeks ]
    The number of unique microbial species associated with OM severity will be compared at each follow-up visit and between the two groups.

  2. Number of oral microbial species [ Time Frame: 16 weeks ]
    The number of each type of microbial species associated with OM severity will be quantified and compared at each follow-up visit and between the two groups.

  3. Levels of salivary proinflammatory cytokines [ Time Frame: 16 weeks ]
    The level of salivary proinflammatory cytokines will be compared between the two groups at each follow-up visit.

  4. Quality of Life as measured by the composite score of the EORTC [ Time Frame: 16 weeks ]
    Quality of life will be measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC) and Head & Neck module (EORTC-H&N) and compared between the two groups at each follow-up visit.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608879


Locations
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United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Patricia Corby, DDS, MS NYU Langone Medical Center

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02608879     History of Changes
Other Study ID Numbers: 14-00082
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016

Keywords provided by NYU Langone Health:
proinflammatory cytokines
microbiome
radiation therapy

Additional relevant MeSH terms:
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Mouth Neoplasms
Mouth Diseases
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mucositis
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomatognathic Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents