Clinical trial NCT02608879: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Mucositis
Oral Cancer
Keywords: proinflammatory cytokines
microbiome
radiation therapy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Oral Mucositis Severity - WHO Scale
timeFrame: End of Radiation Treatment (approximately week 7)
measure: Oral Mucositis Severity - NCI Scale
timeFrame: End of Radiation Treatment (approximately week 7)
Secondary outcomes:
measure: Level of Oral Pain (FACES Scale)
timeFrame: End of Radiation Treatment (approximately week 7)
measure: Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Right Side) From Baseline to Onset of Oral Mucositis
timeFrame: Baseline to Onset of Oral Mucositis
measure: Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Left Side) From Baseline to Onset of Oral Mucositis
timeFrame: Baseline to Onset of Oral Mucositis
measure: Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Right Side) From Baseline to Onset of Oral Mucositis
timeFrame: Baseline to Onset of Oral Mucositis
measure: Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Left Side) From Baseline to Onset of Oral Mucositis
timeFrame: Baseline to Onset of Oral Mucositis
measure: Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks
timeFrame: Baseline and 16 weeks (final study visit)
measure: Change in Quality of Life as Measured by the Composite Score of the EORTC
timeFrame: Baseline to the peak of mucositis (approximately week 4)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Patricia Corby, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: