Oral Cancer, Oral Mucositis
Conditions
Keywords
proinflammatory cytokines, microbiome, radiation therapy
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.
Interventions
PROCEDUREOral 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.
PROCEDUREStandard 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.
PROCEDUREDental scaling, ultrasonic
An ultrasonic dental scaler will be used to clean the teeth
OTHERChlorhexidine
Non-alcoholic chlorhexidine will be used as part of the OMDP protocol
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral Mucositis Severity - WHO Scale | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Left Side) From Baseline to Onset of Oral Mucositis | 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. |
| Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Right Side) From Baseline to Onset of Oral Mucositis | 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. |
| Level of Oral Pain (FACES Scale) | End of Radiation Treatment (approximately week 7) | 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 |
| Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks | Baseline and 16 weeks (final study visit) | The level of salivary proinflammatory cytokines will be compared between the two groups at each follow-up visit. |
| Change in Quality of Life as Measured by the Composite Score of the EORTC | Baseline to the peak of mucositis (approximately week 4) | 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). |
| Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Left Side) From Baseline to Onset of Oral Mucositis | 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. |
| Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Right Side) From Baseline to Onset of Oral Mucositis | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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.
Dental scaling, ultrasonic: An ultrasonic dental scaler will be used to clean the teeth
Chlorhexidine: Non-alcoholic chlorhexidine will be used as part of the OMDP protocol | 10 |
| 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.
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. | 6 |
| Not Randomized Subjects in this study were randomized at the time oral mucositis (OM) was developed (approximately week 2-4). Subjects who met inclusion criteria at the time of enrollment, but did not meet continuation criteria at the time OM was developed were not randomized and were dropped from the study. | 3 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Did not meet continuation criteria | 0 | 0 | 3 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Control Group | OMDP Group | Not Randomized | Total |
|---|---|---|---|---|
| Age, Continuous | 55.5 years | 55.8 years | 67.33 years | 57.5 years |
| Race/Ethnicity, Customized American Indian or Alaskan | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 0 participants | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Black, not of Hispanic-American Origin | 1 participants | 1 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Hispanic-American | 0 participants | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Other/Unknown | 0 participants | 1 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized White, not of Hispanic-American Origin | 4 participants | 6 participants | 1 participants | 11 participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 1 Participants | 7 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 2 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 10 | 6 / 6 | 2 / 3 |
| serious Total, serious adverse events | 1 / 10 | 0 / 6 | 1 / 3 |
Outcome results
Primary
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: 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
Time frame: End of Radiation Treatment (approximately week 7)
Population: Data from the one participant in the OMDP group who was lost to follow up was not analyzed for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OMDP Group | Oral Mucositis Severity - NCI Scale | CTCAE score of 2 | 2 participants |
| OMDP Group | Oral Mucositis Severity - NCI Scale | CTCAE score of 4 | 0 participants |
| OMDP Group | Oral Mucositis Severity - NCI Scale | CTCAE score of 3 | 1 participants |
| OMDP Group | Oral Mucositis Severity - NCI Scale | CTCAE score of 5 | 0 participants |
| OMDP Group | Oral Mucositis Severity - NCI Scale | CTCAE score of 1 | 6 participants |
| Control Group | Oral Mucositis Severity - NCI Scale | CTCAE score of 5 | 0 participants |
| Control Group | Oral Mucositis Severity - NCI Scale | CTCAE score of 1 | 3 participants |
| Control Group | Oral Mucositis Severity - NCI Scale | CTCAE score of 2 | 1 participants |
| Control Group | Oral Mucositis Severity - NCI Scale | CTCAE score of 3 | 2 participants |
| Control Group | Oral Mucositis Severity - NCI Scale | CTCAE score of 4 | 0 participants |
Primary
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 1. Soreness with erythema 2. Erythema, ulcers, can eat solids 3. Ulcers, liquid diet only 4. Alimentation not possible
Time frame: End of Radiation Treatment (approximately week 7)
Population: Data from the one participant in the OMDP group who was lost to follow up was not analyzed for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OMDP Group | Oral Mucositis Severity - WHO Scale | WHO score of 1 | 0 participants |
| OMDP Group | Oral Mucositis Severity - WHO Scale | WHO score of 3 | 0 participants |
| OMDP Group | Oral Mucositis Severity - WHO Scale | WHO score of 2 | 6 participants |
| OMDP Group | Oral Mucositis Severity - WHO Scale | WHO score of 4 | 0 participants |
| OMDP Group | Oral Mucositis Severity - WHO Scale | WHO score of 0 | 3 participants |
| Control Group | Oral Mucositis Severity - WHO Scale | WHO score of 4 | 1 participants |
| Control Group | Oral Mucositis Severity - WHO Scale | WHO score of 0 | 3 participants |
| Control Group | Oral Mucositis Severity - WHO Scale | WHO score of 1 | 0 participants |
| Control Group | Oral Mucositis Severity - WHO Scale | WHO score of 2 | 2 participants |
| Control Group | Oral Mucositis Severity - WHO Scale | WHO score of 3 | 0 participants |
Secondary
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).
Time frame: Baseline to the peak of mucositis (approximately week 4)
Population: Only data from subjects with oropharyngeal cancer were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OMDP Group | Change in Quality of Life as Measured by the Composite Score of the EORTC | Physical Functioning Score | 11.7 units on a scale | Standard Deviation 8.4 |
| OMDP Group | Change in Quality of Life as Measured by the Composite Score of the EORTC | Global Health Status | -20.9 units on a scale | Standard Deviation 16 |
| OMDP Group | Change in Quality of Life as Measured by the Composite Score of the EORTC | H&N Swallowing Scale | 2 units on a scale | Standard Deviation 23.1 |
| Control Group | Change in Quality of Life as Measured by the Composite Score of the EORTC | Physical Functioning Score | -3.9 units on a scale | Standard Deviation 6.1 |
| Control Group | Change in Quality of Life as Measured by the Composite Score of the EORTC | Global Health Status | -3.4 units on a scale | Standard Deviation 7.3 |
| Control Group | Change in Quality of Life as Measured by the Composite Score of the EORTC | H&N Swallowing Scale | -10 units on a scale | Standard Deviation 22.1 |
Secondary
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.
Time frame: Baseline and 16 weeks (final study visit)
Population: Due to financial limitations, not all data could be analyzed at this time. Samples were collected and may be analyzed at a later point. Analyzed samples were limited to those collected from subjects with oropharyngeal cancer (i.e. samples from subjects with cancer of the oral cavity were not analyzed at this time).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OMDP Group | Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks | IL-12p70 | -0.4503 pg/mL | Standard Deviation 0.0823 |
| OMDP Group | Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks | IL-2 | -0.2754 pg/mL | Standard Deviation 0.0142 |
| OMDP Group | Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks | TNF-α | -0.5881 pg/mL | Standard Deviation 0.0627 |
| OMDP Group | Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks | IFN-ɣ | -0.7228 pg/mL | Standard Deviation 0.18 |
| OMDP Group | Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks | IL-1 | -0.7184 pg/mL | Standard Deviation 0.3918 |
| OMDP Group | Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks | IL-10 | -0.4503 pg/mL | Standard Deviation 0.0823 |
| OMDP Group | Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks | IL-13 | -0.8873 pg/mL | Standard Deviation 0.2511 |
| OMDP Group | Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks | IL-4 | -0.3639 pg/mL | Standard Deviation 1.3222 |
| OMDP Group | Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks | IL-6 | -0.5358 pg/mL | Standard Deviation 0.9856 |
| OMDP Group | Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks | IL-8 | -0.7407 pg/mL | Standard Deviation 0.2868 |
| Control Group | Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks | IL-4 | 0.2911 pg/mL | Standard Deviation 0.2911 |
| Control Group | Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks | IL-12p70 | 0.3603 pg/mL | Standard Deviation 0.3603 |
| Control Group | Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks | IL-10 | 0.3603 pg/mL | Standard Deviation 0.3603 |
| Control Group | Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks | IL-2 | 0.2203 pg/mL | Standard Deviation 0.2203 |
| Control Group | Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks | IL-8 | 0.5925 pg/mL | Standard Deviation 0.5925 |
| Control Group | Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks | TNF-α | 0.4705 pg/mL | Standard Deviation 0.4705 |
| Control Group | Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks | IL-13 | 0.7099 pg/mL | Standard Deviation 0.7099 |
| Control Group | Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks | IFN-ɣ | 0.5782 pg/mL | Standard Deviation 0.5782 |
| Control Group | Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks | IL-6 | 0.4286 pg/mL | Standard Deviation 0.4286 |
| Control Group | Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks | IL-1 | 0.5747 pg/mL | Standard Deviation 0.5747 |
Secondary
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
Time frame: End of Radiation Treatment (approximately week 7)
Population: Data from the one participant in the OMDP group who was lost to follow up was not analyzed for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OMDP Group | Level of Oral Pain (FACES Scale) | FACES score of 10 | 0 participants |
| OMDP Group | Level of Oral Pain (FACES Scale) | FACES score of 0 | 0 participants |
| OMDP Group | Level of Oral Pain (FACES Scale) | FACES score of 2 | 6 participants |
| OMDP Group | Level of Oral Pain (FACES Scale) | FACES score of 4 | 1 participants |
| OMDP Group | Level of Oral Pain (FACES Scale) | FACES score of 8 | 1 participants |
| OMDP Group | Level of Oral Pain (FACES Scale) | FACES score of 6 | 1 participants |
| Control Group | Level of Oral Pain (FACES Scale) | FACES score of 8 | 0 participants |
| Control Group | Level of Oral Pain (FACES Scale) | FACES score of 10 | 0 participants |
| Control Group | Level of Oral Pain (FACES Scale) | FACES score of 4 | 1 participants |
| Control Group | Level of Oral Pain (FACES Scale) | FACES score of 0 | 1 participants |
| Control Group | Level of Oral Pain (FACES Scale) | FACES score of 6 | 1 participants |
| Control Group | Level of Oral Pain (FACES Scale) | FACES score of 2 | 3 participants |
Secondary
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.
Time frame: Baseline to Onset of Oral Mucositis
Population: This outcome measure was only collected in the OMDP Group because this is the only arm where participants developed Oral Mucositis.~Two subjects were excluded from this analysis due to a diagnosis of HIV, which the investigator determined would alter the microbial makeup of the oral cavity.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| OMDP Group | Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Left Side) From Baseline to Onset of Oral Mucositis | Stomatobaculum sp oral taxon 97 | 2.5104787 Proportion of oral microbial species |
| OMDP Group | Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Left Side) From Baseline to Onset of Oral Mucositis | Fusobacterium periodonticum | 2.3367705 Proportion of oral microbial species |
| OMDP Group | Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Left Side) From Baseline to Onset of Oral Mucositis | Leptotrichia sp oral taxon 417 | 1.7988509 Proportion of oral microbial species |
| OMDP Group | Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Left Side) From Baseline to Onset of Oral Mucositis | Gemella Haemolysans | -0.6947840 Proportion of oral microbial species |
| OMDP Group | Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Left Side) From Baseline to Onset of Oral Mucositis | Prevotella histicolla | -0.8316186 Proportion of oral microbial species |
Secondary
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.
Time frame: Baseline to Onset of Oral Mucositis
Population: Data were only collected for the OMDP Grouip because they are the only group that developed oral mucositis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| OMDP Group | Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Right Side) From Baseline to Onset of Oral Mucositis | Stomatobaculum sp oral taxon 97 | 2.6517 Proportion of oral microbial species |
| OMDP Group | Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Right Side) From Baseline to Onset of Oral Mucositis | Leptotrichia sp oral taxon | 1.8354 Proportion of oral microbial species |
| OMDP Group | Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Right Side) From Baseline to Onset of Oral Mucositis | Haemophillus Genus probe 3 | -2.2123 Proportion of oral microbial species |
| OMDP Group | Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Right Side) From Baseline to Onset of Oral Mucositis | Veillonella Genus probe 2 | -0.9269246 Proportion of oral microbial species |
| OMDP Group | Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Right Side) From Baseline to Onset of Oral Mucositis | Gemella Haemolysans | -0.7559120 Proportion of oral microbial species |
Secondary
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.
Time frame: Baseline to Onset of Oral Mucositis
Population: This outcome measure was only collected in the OMDP Group because this is the only arm where participants developed Oral Mucositis.~Two subjects were excluded from this analysis due to a diagnosis of HIV, which the investigator determined would alter the microbial makeup of the oral cavity.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| OMDP Group | Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Left Side) From Baseline to Onset of Oral Mucositis | Gemella Haemolysans | -1.5662996 Proportion of oral microbial species |
| OMDP Group | Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Left Side) From Baseline to Onset of Oral Mucositis | Gemella Sanguinis | 3.1061673 Proportion of oral microbial species |
| OMDP Group | Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Left Side) From Baseline to Onset of Oral Mucositis | Stomatobaculum sp oral taxon 97 | 3.6522501 Proportion of oral microbial species |
| OMDP Group | Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Left Side) From Baseline to Onset of Oral Mucositis | Fusobacterium periodonticum | 2.8036767 Proportion of oral microbial species |
| OMDP Group | Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Left Side) From Baseline to Onset of Oral Mucositis | Haemophillus Genus probe 3 | -2.9178458 Proportion of oral microbial species |
Secondary
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.
Time frame: Baseline to Onset of Oral Mucositis
Population: This outcome measure was only collected in the OMDP Group because this is the only arm where participants developed Oral Mucositis.~Two subjects were excluded from this analysis due to a diagnosis of HIV, which the investigator determined would alter the microbial makeup of the oral cavity.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| OMDP Group | Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Right Side) From Baseline to Onset of Oral Mucositis | Streptococcus Genus probe 1 | -0.9359749 Proportion of oral microbial species |
| OMDP Group | Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Right Side) From Baseline to Onset of Oral Mucositis | Haemophillus Genus probe 3 | -3.545091 Proportion of oral microbial species |
| OMDP Group | Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Right Side) From Baseline to Onset of Oral Mucositis | Gemella Haemolysans | -2.1439002 Proportion of oral microbial species |
| OMDP Group | Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Right Side) From Baseline to Onset of Oral Mucositis | Leptotrichia sp oral taxon 417 | 1.3618774 Proportion of oral microbial species |
| OMDP Group | Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Right Side) From Baseline to Onset of Oral Mucositis | Gemella Sanguinis | 2.9317234 Proportion of oral microbial species |