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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Mucosa Deterging and Periodontal Debridement (OMDP) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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
| 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:
| End of Radiation Treatment (approximately week 7) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Corby, DDS, MS | NYU Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Medical Center | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Standard of Care Oral Hygiene Instructions | Procedure | 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. |
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| Dental scaling, ultrasonic | Procedure | An ultrasonic dental scaler will be used to clean the teeth |
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| Chlorhexidine | Other | Non-alcoholic chlorhexidine will be used as part of the OMDP protocol |
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| 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. | 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. | 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. | 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. | 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. | 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). | Baseline to the peak of mucositis (approximately week 4) |
| FG001 | 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. |
| FG002 | 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. |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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
| Data from the one participant in the OMDP group who was lost to follow up was not analyzed for this measure. | Posted | Number | participants | End of Radiation Treatment (approximately week 7) |
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| 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:
| Data from the one participant in the OMDP group who was lost to follow up was not analyzed for this measure. | Posted | Number | participants | End of Radiation Treatment (approximately week 7) |
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| 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 | Data from the one participant in the OMDP group who was lost to follow up was not analyzed for this measure. | Posted | Number | participants | End of Radiation Treatment (approximately week 7) |
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| 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. | Data were only collected for the OMDP Grouip because they are the only group that developed oral mucositis. | Posted | Mean | 95% Confidence Interval | Proportion of oral microbial species | Baseline to Onset of Oral Mucositis |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | Proportion of oral microbial species | Baseline to Onset of Oral Mucositis |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | Proportion of oral microbial species | Baseline to Onset of Oral Mucositis |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | Proportion of oral microbial species | Baseline to Onset of Oral Mucositis |
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| 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. | 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). | Posted | Mean | Standard Deviation | pg/mL | Baseline and 16 weeks (final study visit) |
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| 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). | Only data from subjects with oropharyngeal cancer were included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline to the peak of mucositis (approximately week 4) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 1 | 10 | 10 | 10 | ||
| EG001 | 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. | 0 | 6 | 6 | 6 | ||
| EG002 | 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. | 1 | 3 | 2 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal liver function | Hepatobiliary disorders | Non-systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oral Mucositis | Gastrointestinal disorders | Systematic Assessment |
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| Allergic reaction | General disorders | Non-systematic Assessment |
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| Candidiasis | Infections and infestations | Systematic Assessment |
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| Dry Mouth/throat | Gastrointestinal disorders | Non-systematic Assessment |
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| Sore throat | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Dehydration | General disorders | Non-systematic Assessment |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Cacogeusia | Gastrointestinal disorders | Non-systematic Assessment |
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| Edema | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Lymphoedema | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Dysgeusia | Gastrointestinal disorders | Non-systematic Assessment |
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| Radiation dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Shingles | Infections and infestations | Non-systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
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| Hearing loss | Ear and labyrinth disorders | Non-systematic Assessment |
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| Cold/flu | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Chemotherapy induced rash | Surgical and medical procedures | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Hiccups with acid reflux | Gastrointestinal disorders | Non-systematic Assessment |
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| Heartburn | Gastrointestinal disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Shoulder pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Hypogeusia | Gastrointestinal disorders | Non-systematic Assessment |
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| Burning on the tongue | Gastrointestinal disorders | Non-systematic Assessment |
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| Herpetic lesion | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia Corby, Principal Investigator | NYU Langone Medical Center | 646-501-2615 | patricia.corby@nyumc.org |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009062 | Mouth Neoplasms |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D057747 | Periodontal Debridement |
| D012534 | Dental Scaling |
| D019220 | High-Energy Shock Waves |
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D003777 | Dental Prophylaxis |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D011313 | Preventive Dentistry |
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Male |
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| Asian or Pacific Islander |
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| Black, not of Hispanic-American Origin |
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| Hispanic-American |
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| White, not of Hispanic-American Origin |
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| Other/Unknown |
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| WHO score of 2 |
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| WHO score of 3 |
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| WHO score of 4 |
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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. |
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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.
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| OG001 | 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. |
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