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
|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|
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 (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
Non-alcoholic chlorhexidine will be used as part of the OMDP protocol
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|United States, New York|
|NYU Langone Medical Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Patricia Corby, DDS, MS||NYU Langone Medical Center|