Trial Outcomes & Findings for Oral Care Protocol for the Management of Chemotherapy and Radiation Therapy-Induced Oral Mucositis (NCT NCT02608879)
NCT ID: NCT02608879
Last Updated: 2020-08-28
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
End of Radiation Treatment (approximately week 7)
Results posted on
2020-08-28
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
3
|
|
Overall Study
COMPLETED
|
9
|
6
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
3
|
Reasons for withdrawal
| Measure |
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
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Did not meet continuation criteria
|
0
|
0
|
3
|
Baseline Characteristics
Oral Care Protocol for the Management of Chemotherapy and Radiation Therapy-Induced Oral Mucositis
Baseline characteristics by cohort
| Measure |
OMDP Group
n=10 Participants
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
|
Control Group
n=6 Participants
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.
|
Not Randomized
n=3 Participants
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.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.8 years
n=93 Participants
|
55.5 years
n=4 Participants
|
67.33 years
n=27 Participants
|
57.5 years
n=483 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
1 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
1 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Black, not of Hispanic-American Origin
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
2 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Hispanic-American
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
1 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White, not of Hispanic-American Origin
|
6 participants
n=93 Participants
|
4 participants
n=4 Participants
|
1 participants
n=27 Participants
|
11 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
2 participants
n=27 Participants
|
3 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
OMDP Group
n=9 Participants
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
|
Control Group
n=6 Participants
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.
|
|---|---|---|
|
Oral Mucositis Severity - WHO Scale
WHO score of 0
|
3 participants
|
3 participants
|
|
Oral Mucositis Severity - WHO Scale
WHO score of 1
|
0 participants
|
0 participants
|
|
Oral Mucositis Severity - WHO Scale
WHO score of 2
|
6 participants
|
2 participants
|
|
Oral Mucositis Severity - WHO Scale
WHO score of 3
|
0 participants
|
0 participants
|
|
Oral Mucositis Severity - WHO Scale
WHO score of 4
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
OMDP Group
n=9 Participants
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
|
Control Group
n=6 Participants
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.
|
|---|---|---|
|
Oral Mucositis Severity - NCI Scale
CTCAE score of 1
|
6 participants
|
3 participants
|
|
Oral Mucositis Severity - NCI Scale
CTCAE score of 2
|
2 participants
|
1 participants
|
|
Oral Mucositis Severity - NCI Scale
CTCAE score of 3
|
1 participants
|
2 participants
|
|
Oral Mucositis Severity - NCI Scale
CTCAE score of 4
|
0 participants
|
0 participants
|
|
Oral Mucositis Severity - NCI Scale
CTCAE score of 5
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
OMDP Group
n=9 Participants
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
|
Control Group
n=6 Participants
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.
|
|---|---|---|
|
Level of Oral Pain (FACES Scale)
FACES score of 4
|
1 participants
|
1 participants
|
|
Level of Oral Pain (FACES Scale)
FACES score of 0
|
0 participants
|
1 participants
|
|
Level of Oral Pain (FACES Scale)
FACES score of 2
|
6 participants
|
3 participants
|
|
Level of Oral Pain (FACES Scale)
FACES score of 6
|
1 participants
|
1 participants
|
|
Level of Oral Pain (FACES Scale)
FACES score of 8
|
1 participants
|
0 participants
|
|
Level of Oral Pain (FACES Scale)
FACES score of 10
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to Onset of Oral MucositisPopulation: Data were only collected for the OMDP Grouip because they are the only group that developed 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.
Outcome measures
| Measure |
OMDP Group
n=9 Participants
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
|
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.
|
|---|---|---|
|
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
Interval 0.7038302 to 4.5995841
|
—
|
|
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
Interval 0.1348964 to 3.5358455
|
—
|
|
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
Interval -4.2835766 to -0.1410081
|
—
|
|
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
Interval -1.8325844 to -0.0212649
|
—
|
|
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
Interval -1.6171195 to 0.1052956
|
—
|
SECONDARY outcome
Timeframe: Baseline to Onset of Oral MucositisPopulation: 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.
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.
Outcome measures
| Measure |
OMDP Group
n=9 Participants
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
|
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.
|
|---|---|---|
|
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
Interval 0.5610779 to 4.1124631
|
—
|
|
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
Interval 0.3998338 to 3.19778681
|
—
|
|
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
Interval 0.481014 to 4.5399434
|
—
|
|
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
Interval -1.6371024 to 0.2475345
|
—
|
|
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
Interval -2.0134734 to 0.3502363
|
—
|
SECONDARY outcome
Timeframe: Baseline to Onset of Oral MucositisPopulation: 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.
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.
Outcome measures
| Measure |
OMDP Group
n=9 Participants
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
|
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.
|
|---|---|---|
|
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
Interval -4.9414618 to -2.1487203
|
—
|
|
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
Interval -3.2226984 to -1.065102
|
—
|
|
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
Interval -1.5210515 to -0.3508983
|
—
|
|
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
Interval 0.3917063 to 2.3320485
|
—
|
|
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
Interval 0.8166947 to 4.8467521
|
—
|
SECONDARY outcome
Timeframe: Baseline to Onset of Oral MucositisPopulation: 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.
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.
Outcome measures
| Measure |
OMDP Group
n=9 Participants
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
|
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.
|
|---|---|---|
|
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
Interval 1.6923225 to 4.50012
|
—
|
|
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
Interval 1.9517525 to 5.3527476
|
—
|
|
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
Interval 1.3181513 to 4.2892021
|
—
|
|
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
Interval -2.4326884 to -0.6999108
|
—
|
|
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
Interval -4.6320329 to -1.2036587
|
—
|
SECONDARY outcome
Timeframe: 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).
The level of salivary proinflammatory cytokines will be compared between the two groups at each follow-up visit.
Outcome measures
| Measure |
OMDP Group
n=5 Participants
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
|
Control Group
n=5 Participants
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.
|
|---|---|---|
|
Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks
IL-4
|
-0.3639 pg/mL
Standard Deviation 1.3222
|
0.2911 pg/mL
Standard Deviation 0.2911
|
|
Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks
IFN-É£
|
-0.7228 pg/mL
Standard Deviation 0.18
|
0.5782 pg/mL
Standard Deviation 0.5782
|
|
Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks
IL-1
|
-0.7184 pg/mL
Standard Deviation 0.3918
|
0.5747 pg/mL
Standard Deviation 0.5747
|
|
Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks
IL-10
|
-0.4503 pg/mL
Standard Deviation 0.0823
|
0.3603 pg/mL
Standard Deviation 0.3603
|
|
Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks
IL-12p70
|
-0.4503 pg/mL
Standard Deviation 0.0823
|
0.3603 pg/mL
Standard Deviation 0.3603
|
|
Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks
IL-13
|
-0.8873 pg/mL
Standard Deviation 0.2511
|
0.7099 pg/mL
Standard Deviation 0.7099
|
|
Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks
IL-2
|
-0.2754 pg/mL
Standard Deviation 0.0142
|
0.2203 pg/mL
Standard Deviation 0.2203
|
|
Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks
IL-6
|
-0.5358 pg/mL
Standard Deviation 0.9856
|
0.4286 pg/mL
Standard Deviation 0.4286
|
|
Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks
IL-8
|
-0.7407 pg/mL
Standard Deviation 0.2868
|
0.5925 pg/mL
Standard Deviation 0.5925
|
|
Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks
TNF-α
|
-0.5881 pg/mL
Standard Deviation 0.0627
|
0.4705 pg/mL
Standard Deviation 0.4705
|
SECONDARY outcome
Timeframe: Baseline to the peak of mucositis (approximately week 4)Population: Only data from subjects with oropharyngeal cancer were included in this analysis.
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).
Outcome measures
| Measure |
OMDP Group
n=5 Participants
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
|
Control Group
n=5 Participants
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.
|
|---|---|---|
|
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
|
-3.9 units on a scale
Standard Deviation 6.1
|
|
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
|
-3.4 units on a scale
Standard Deviation 7.3
|
|
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
|
-10 units on a scale
Standard Deviation 22.1
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Not Randomized
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
OMDP Group
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Group
n=6 participants at risk
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.
|
Not Randomized
n=3 participants at risk
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.
|
OMDP Group
n=10 participants at risk
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
|
|---|---|---|---|
|
Hepatobiliary disorders
Abnormal liver function
|
0.00%
0/6
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/10
|
Other adverse events
| Measure |
Control Group
n=6 participants at risk
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.
|
Not Randomized
n=3 participants at risk
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.
|
OMDP Group
n=10 participants at risk
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
|
|---|---|---|---|
|
Gastrointestinal disorders
Oral Mucositis
|
100.0%
6/6
|
66.7%
2/3
|
100.0%
10/10
|
|
General disorders
Allergic reaction
|
16.7%
1/6
|
0.00%
0/3
|
10.0%
1/10
|
|
Infections and infestations
Candidiasis
|
33.3%
2/6
|
33.3%
1/3
|
50.0%
5/10
|
|
Gastrointestinal disorders
Dry Mouth/throat
|
83.3%
5/6
|
0.00%
0/3
|
70.0%
7/10
|
|
Gastrointestinal disorders
Sore throat
|
50.0%
3/6
|
0.00%
0/3
|
10.0%
1/10
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6
|
0.00%
0/3
|
70.0%
7/10
|
|
General disorders
Dehydration
|
0.00%
0/6
|
0.00%
0/3
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
16.7%
1/6
|
0.00%
0/3
|
0.00%
0/10
|
|
Gastrointestinal disorders
Cacogeusia
|
16.7%
1/6
|
0.00%
0/3
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Edema
|
0.00%
0/6
|
0.00%
0/3
|
10.0%
1/10
|
|
Blood and lymphatic system disorders
Lymphoedema
|
16.7%
1/6
|
0.00%
0/3
|
0.00%
0/10
|
|
Gastrointestinal disorders
Dysgeusia
|
16.7%
1/6
|
0.00%
0/3
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
Radiation dermatitis
|
33.3%
2/6
|
0.00%
0/3
|
0.00%
0/10
|
|
General disorders
Fatigue
|
16.7%
1/6
|
33.3%
1/3
|
0.00%
0/10
|
|
Infections and infestations
Shingles
|
16.7%
1/6
|
0.00%
0/3
|
0.00%
0/10
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6
|
0.00%
0/3
|
10.0%
1/10
|
|
Ear and labyrinth disorders
Hearing loss
|
0.00%
0/6
|
0.00%
0/3
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Cold/flu
|
0.00%
0/6
|
0.00%
0/3
|
10.0%
1/10
|
|
Surgical and medical procedures
Chemotherapy induced rash
|
0.00%
0/6
|
0.00%
0/3
|
10.0%
1/10
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6
|
0.00%
0/3
|
10.0%
1/10
|
|
Gastrointestinal disorders
Hiccups with acid reflux
|
0.00%
0/6
|
0.00%
0/3
|
10.0%
1/10
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/6
|
0.00%
0/3
|
10.0%
1/10
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6
|
0.00%
0/3
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.00%
0/6
|
0.00%
0/3
|
10.0%
1/10
|
|
Gastrointestinal disorders
Hypogeusia
|
0.00%
0/6
|
0.00%
0/3
|
10.0%
1/10
|
|
Gastrointestinal disorders
Burning on the tongue
|
0.00%
0/6
|
0.00%
0/3
|
10.0%
1/10
|
|
Infections and infestations
Herpetic lesion
|
0.00%
0/6
|
0.00%
0/3
|
10.0%
1/10
|
Additional Information
Patricia Corby, Principal Investigator
NYU Langone Medical Center
Phone: 646-501-2615
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place