Oral MucositisOMDPNCT02608879
Oral Care Protocol for the Management of Chemotherapy and Radiation Therapy-Induced Oral Mucositis
A study testing Oral Mucosa Deterging and Periodontal Debridement (OMDP), Dental scaling, ultrasonic and Chlorhexidine in people with Oral Mucositis and Oral Cancer, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis, Oral Cancer
- What is being tested?
- Oral Mucosa Deterging and Periodontal Debridement (OMDP), Dental scaling, ultrasonic and Chlorhexidine
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patient aged 18 years or older;
- Patients must sign an informed consent before data collection, screening, or initiation of study procedures;
- Patients who are scheduled to undergo radiation or chemoradiation treatment for head/neck cancer;
- Patients who have a minimum of 6 natural teeth at the time of enrollment.
Who cannot join
- Female patients who are pregnant or lactating at the baseline/screening visit;
- Patient participating in another biomedical/oral health research study that would interfere with participating in this study;
- Patient deprived of freedom, under supervision or guardianship;
- Patient unable to attend to scheduled medical monitoring due to geographical, social or mental reasons;
- Immune compromised or other serious medical conditions, regardless of whether the condition is controlled or not;
- Patient who requires pre-medication prior to dental treatment;
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center
New York, New York, 10016
About this study
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.
Read the 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
- Being tested
- Oral Mucosa Deterging and Periodontal Debridement (OMDP), Standard of Care Oral Hygiene Instructions, Dental scaling, ultrasonic, Chlorhexidine
- Keywords
- proinflammatory cytokines, microbiome, radiation therapy
- Medical subject headings
- Stomatitis, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Mucosa Deterging and Periodontal Debridement (OMDP)Procedure or surgery
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.
Standard of Care Oral Hygiene InstructionsProcedure or surgery
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.
Dental scaling, ultrasonicProcedure or surgery
An ultrasonic dental scaler will be used to clean the teeth
ChlorhexidineOther
Non-alcoholic chlorhexidine will be used as part of the OMDP protocol
| Study group | Role | What they receive |
|---|---|---|
| OMDP Group | Experimental | 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. Receives: Procedure: Oral Mucosa Deterging and Periodontal Debridement (OMDP); Procedure: Dental scaling, ultrasonic; Other: Chlorhexidine |
| Control Group | Other | 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. Receives: Procedure: Standard of Care Oral Hygiene Instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Mucositis Severity - WHO Scale
OM severity will be assessed by the WHO Oral Mucositis Scale at each follow-up visit.
The WHO Oral Mucositis Scale is a 5 point scale (0 to 4) with the following scoring system:
0=None
- Soreness with erythema
- Erythema, ulcers, can eat solids
- Ulcers, liquid diet only
- Alimentation not possible
Measured: End of Radiation Treatment (approximately week 7)
Oral Mucositis Severity - NCI Scale
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.
The NCI-CTCAE is a 5 point scale (1-5) with the following grading system:
- Erythema of the mucosa
- Patchy ulcerations or pseudomembranes
- Confluent ulcerations or pseudomembranes; bleeding with minor trauma
- Tissue necrosis; significant spontaneous bleeding; life-threatening consequences
- Death
Measured: End of Radiation Treatment (approximately week 7)
Secondary outcomes (7)
Level of Oral Pain (FACES Scale)
The FACES Scale is a 6 point scale which ranges from 0-10 (and includes even numbers only). The scale is accompanied by illustrations of faces which represent each score. The subjects is shown the scale and asked to choose the face that best depicts the pain they are experiencing.
0=No hurt 2=Hurts a little bit 4=Hurts a little more 6=Hurts even more 8=Hurts a whole lot 10-Hurts the worst you could imagine
Measured: End of Radiation Treatment (approximately week 7)
Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Right Side) From Baseline to Onset of Oral Mucositis
The number of each type of microbial species will be quantified and compared at each follow-up visit. Relative abundance for each species will be measured and reported. Relative abundance is a measure of the proportion of an organism of a particular kind (in this case, each microbial species) relative to the total number of organisms (the other microbial species) in the area.
A positive mean value indicates that the species was present in greater quantities at baseline. A negative mean value indicates that the species was present in greater quantities at onset of oral mucositis.
For this data, the top five most abundant microbial species are presented.
Measured: Baseline to Onset of Oral Mucositis
Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Left Side) From Baseline to Onset of Oral Mucositis
The number of each type of microbial species will be quantified and compared at each follow-up visit. Relative abundance for each species will be measured and reported. Relative abundance is a measure of the proportion of an organism of a particular kind (in this case, each microbial species) relative to the total number of organisms (the other microbial species) in the area.
A positive mean value indicates that the species was present in greater quantities at baseline. A negative mean value indicates that the species was present in greater quantities at onset of oral mucositis.
For this data, the top five most abundant microbial species are presented.
Measured: Baseline to Onset of Oral Mucositis
Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Right Side) From Baseline to Onset of Oral Mucositis
The number of each type of microbial species will be quantified and compared at each follow-up visit. Relative abundance for each species will be measured and reported. Relative abundance is a measure of the proportion of an organism of a particular kind (in this case, each microbial species) relative to the total number of organisms (the other microbial species) in the area.
A positive mean value indicates that the species was present in greater quantities at baseline. A negative mean value indicates that the species was present in greater quantities at onset of oral mucositis.
For this data, the top five most abundant microbial species are presented.
Measured: Baseline to Onset of Oral Mucositis
Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Left Side) From Baseline to Onset of Oral Mucositis
The number of each type of microbial species will be quantified and compared at each follow-up visit. Relative abundance for each species will be measured and reported. Relative abundance is a measure of the proportion of an organism of a particular kind (in this case, each microbial species) relative to the total number of organisms (the other microbial species) in the area.
A positive mean value indicates that the species was present in greater quantities at baseline. A negative mean value indicates that the species was present in greater quantities at onset of oral mucositis.
For this data, the top five most abundant microbial species are presented.
Measured: Baseline to Onset of Oral Mucositis
Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks
The level of salivary proinflammatory cytokines will be compared between the two groups at each follow-up visit.
Measured: Baseline and 16 weeks (final study visit)
Change in Quality of Life as Measured by the Composite Score of the EORTC
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.
There is not a single composite score for the entire questionnaire, but rather composite scores for each type of assessment (e.g. physical functioning, global health, swallowing, etc.). Possible scores range from 0-100. A lower score indicates low levels of that trait, which a higher score indicates high levels of that trait (e.g. a 100 for "physical functioning" indicates a high level of physical function).
Measured: Baseline to the peak of mucositis (approximately week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startMar 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Corby, DDS, MS, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608879
- Sponsor's protocol ID
- 14-00082
- Acronym
- OMDP
- Status last verified
- Aug 2020
- First submitted
- 13 Nov 2015
- Last updated
- 28 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Care Protocol for the Management of Chemotherapy and Radiation Therapy-Induced Oral Mucositis
- ClinicalTrials.gov ID
- NCT02608879
- Acronym / sponsor ID
- OMDP / 14-00082
- Conditions
- Oral Mucositis, Oral Cancer
- Keywords
- proinflammatory cytokines, microbiome, radiation therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Posted 28 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMDP Group | Experimental | Procedure: Oral Mucosa Deterging and Periodontal Debridement (OMDP), Procedure: Dental scaling, ultrasonic, Other: ChlorhexidineSubjects 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. |
| Control Group | Other | Procedure: Standard of Care Oral Hygiene InstructionsSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patient aged 18 years or older;
- Patients must sign an informed consent before data collection, screening, or initiation of study procedures;
- Patients who are scheduled to undergo radiation or chemoradiation treatment for head/neck cancer;
- Patients who have a minimum of 6 natural teeth at the time of enrollment.
Key exclusion criteria (7 listed)
- Female patients who are pregnant or lactating at the baseline/screening visit;
- Patient participating in another biomedical/oral health research study that would interfere with participating in this study;
- Patient deprived of freedom, under supervision or guardianship;
- Patient unable to attend to scheduled medical monitoring due to geographical, social or mental reasons;
- Immune compromised or other serious medical conditions, regardless of whether the condition is controlled or not;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | OMDP Group |
| Standard of Care Oral Hygiene InstructionsSubjects 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. | Procedure or surgery | Control Group |
| Dental scaling, ultrasonicAn ultrasonic dental scaler will be used to clean the teeth | Procedure or surgery | OMDP Group |
| ChlorhexidineNon-alcoholic chlorhexidine will be used as part of the OMDP protocol | Other | OMDP Group |
Primary outcome
Oral Mucositis Severity - WHO Scale
Time frame: End of Radiation Treatment (approximately week 7)
OM severity will be assessed by the WHO Oral Mucositis Scale at each follow-up visit. The WHO Oral Mucositis Scale is a 5 point scale (0 to 4) with the following scoring system: 0=None 1. Soreness with erythema 2. Erythema, ulcers, can eat solids 3. Ulcers, liquid diet only 4. Alimentation not possible
Oral Mucositis Severity - NCI Scale
Time frame: End of Radiation Treatment (approximately week 7)
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. The NCI-CTCAE is a 5 point scale (1-5) with the following grading system: 1. Erythema of the mucosa 2. Patchy ulcerations or pseudomembranes 3. Confluent ulcerations or pseudomembranes; bleeding with minor trauma 4. Tissue necrosis; significant spontaneous bleeding; life-threatening consequences 5. Death
7 secondary outcomes
Level of Oral Pain (FACES Scale)
Time frame: End of Radiation Treatment (approximately week 7)
Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Right Side) From Baseline to Onset of Oral Mucositis
Time frame: Baseline to Onset of Oral Mucositis
Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Left Side) From Baseline to Onset of Oral Mucositis
Time frame: Baseline to Onset of Oral Mucositis
Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Right Side) From Baseline to Onset of Oral Mucositis
Time frame: Baseline to Onset of Oral Mucositis
Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Left Side) From Baseline to Onset of Oral Mucositis
Time frame: Baseline to Onset of Oral Mucositis
Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks
Time frame: Baseline and 16 weeks (final study visit)
Change in Quality of Life as Measured by the Composite Score of the EORTC
Time frame: Baseline to the peak of mucositis (approximately week 4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Corby, DDS, MS principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Mucosa Deterging and Periodontal Debridement (OMDP), Dental scaling, ultrasonic and Chlorhexidine in people with Oral Mucositis and Oral Cancer, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Mucositis Severity - WHO Scale (time frame: End of Radiation Treatment (approximately week 7)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020.