Trial Outcomes & Findings for Commensal Oral Microbiota in Head and Neck Cancer (NCT NCT03843554)

Last Updated: 2025-09-26

Results Overview

World Health Organization's Oral Toxicity Scale (WHO OTS): Oral mucositis severity as measured by the WHO OTS; severity is graded 0 through 4, with 4 being the worst. Grade 0 (none), Grade 1 (oral soreness, erythema), Grade 2 (ulceration, solid diet tolerated), Grade 3 (ulceration, liquid diet only), and Grade 4 (nothing by mouth).

Recruitment status

TERMINATED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

Week 1 (Day 0/Randomization) - Week 8 (Day 56) during radiation therapy. Change from Baseline to Final Intervention Visit (FIV) is the endpoint being analyzed at this single timepoint (Day 56 relative to Day 0).

Results posted on

2025-09-26

Participant Flow

H\&N cancer patients were recruited to achieve 120 study subjects. The primary recruitment of 60 subjects was done through the UPenn Cancer Center. The sponsor/NIDCR prematurely ceased enrollment in proton therapy. Afterwards, the sponsor terminated the trial with 50% enrollment due to "under-enrollment into specific diverse racial, ethnic, and sex/gender categories." As a result, the analysis are presented for all randomized subjects (30 per arm).

Participant milestones

Participant milestones
Measure	Standard of Care Oral Hygiene Standard of Care Oral Hygiene group (SOC-OH): Subjects assigned to SOC-OH will attend weekly oral care visits where they will have their teeth brushed with a soft bristled toothbrush by the interventionist. No treatment to the oral mucosa will be provided to this group as part of the intervention. Subjects will receive oral care instructions and will be asked to follow SOC oral hygiene instructions at home. Standard of Care Oral Hygiene: Standard of care oral hygiene- weekly oral care visits with soft-bristled toothbrushing.	Oral Mucosal Deterging and Dental Prophylaxis (OMDP) Oral Mucosal Deterging \& Dental Prophylaxis (OMDP) protocol: Subjects assigned to OMDP will attend weekly intervention visits during which they will have their teeth cleaned and will receive the OMDP intervention as follows: subjects will receive a professional dental prophylaxis including periodontal surface debridement and deterging of the oral mucosal surfaces. Subjects will be asked to follow OMDP oral hygiene instructions at home. Oral mucosal deterging and dental prophylaxis: Subjects will receive a professional dental prophylaxis including periodontal surface debridement \[a light-touch, gentle form of instrumentation performed with an ultrasonic instrument to promote plaque removal, to facilitate biofilm disruption and endotoxin flushing, but yet with the preservation of the periodontal cementum\] and deterging of the oral mucosal surfaces\].
Overall Study STARTED	30	30
Overall Study COMPLETED	30	28
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard of Care Oral Hygiene Standard of Care Oral Hygiene group (SOC-OH): Subjects assigned to SOC-OH will attend weekly oral care visits where they will have their teeth brushed with a soft bristled toothbrush by the interventionist. No treatment to the oral mucosa will be provided to this group as part of the intervention. Subjects will receive oral care instructions and will be asked to follow SOC oral hygiene instructions at home. Standard of Care Oral Hygiene: Standard of care oral hygiene- weekly oral care visits with soft-bristled toothbrushing.	Oral Mucosal Deterging and Dental Prophylaxis (OMDP) Oral Mucosal Deterging \& Dental Prophylaxis (OMDP) protocol: Subjects assigned to OMDP will attend weekly intervention visits during which they will have their teeth cleaned and will receive the OMDP intervention as follows: subjects will receive a professional dental prophylaxis including periodontal surface debridement and deterging of the oral mucosal surfaces. Subjects will be asked to follow OMDP oral hygiene instructions at home. Oral mucosal deterging and dental prophylaxis: Subjects will receive a professional dental prophylaxis including periodontal surface debridement \[a light-touch, gentle form of instrumentation performed with an ultrasonic instrument to promote plaque removal, to facilitate biofilm disruption and endotoxin flushing, but yet with the preservation of the periodontal cementum\] and deterging of the oral mucosal surfaces\].
Overall Study Physician Decision	0	2

Baseline Characteristics

The ARMOR Trial employed a two-arm (OMDP vs STANDARD) parallel group design. The goal was to randomize 120 subjects within the 4 strata defined by planned cancer treatment (IMRT versus Proton, with or w/o chemotherapy). The first subject was randomized on 10/11/2019. On 2/19/2021, the study team received a NIDCR/DSMB letter recommending discontinuing enrollment for subjects receiving Proton beam therapy. The trial was closed by the NIDCR on 08/03/22.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Week 1 (Day 0/Randomization) - Week 8 (Day 56) during radiation therapy. Change from Baseline to Final Intervention Visit (FIV) is the endpoint being analyzed at this single timepoint (Day 56 relative to Day 0).

Population: 60 randomized subjects, 30 per arm.

Outcome measures

Outcome measures
Measure	Standard of Care Oral Hygiene n=30 Participants Standard of Care Oral Hygiene group (SOC-OH): Subjects assigned to SOC-OH will attend weekly oral care visits where they will have their teeth brushed with a soft bristled toothbrush by the interventionist. No treatment to the oral mucosa will be provided to this group as part of the intervention. Subjects will receive oral care instructions and will be asked to follow SOC oral hygiene instructions at home. Standard of Care Oral Hygiene: Standard of care oral hygiene- weekly oral care visits with soft-bristled toothbrushing.	Oral Mucosal Deterging and Dental Prophylaxis (OMDP) n=30 Participants Oral Mucosal Deterging \& Dental Prophylaxis (OMDP) protocol: Subjects assigned to OMDP will attend weekly intervention visits during which they will have their teeth cleaned and will receive the OMDP intervention as follows: subjects will receive a professional dental prophylaxis including periodontal surface debridement and deterging of the oral mucosal surfaces. Subjects will be asked to follow OMDP oral hygiene instructions at home. Oral mucosal deterging and dental prophylaxis: Subjects will receive a professional dental prophylaxis including periodontal surface debridement \[a light-touch, gentle form of instrumentation performed with an ultrasonic instrument to promote plaque removal, to facilitate biofilm disruption and endotoxin flushing, but yet with the preservation of the periodontal cementum\] and deterging of the oral mucosal surfaces\].
Oral Mucosal Severity (Grade 3 or 4)	9 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline and final intervention visit.

Population: Inflammation markers were summarized by treatment group, visit and sample type using standard descriptive statistics. The impact of each treatment arm on the change from Baseline to Final Intervention Visit (FIV) for the above inflammation markers was examined and inferential tests such as two-sided t-test (for continuous inflammation scores change).

Salivary cytokines: Levels of Th1/Th2-type cytokines IL10, IL8, IL12p70, TNF alpha, IL4, IL1b, IL2, IL13, IL5, and IFN gamma will be assessed, in addition to levels of gp340.

Outcome measures

Outcome measures
Measure	Standard of Care Oral Hygiene n=30 Participants Standard of Care Oral Hygiene group (SOC-OH): Subjects assigned to SOC-OH will attend weekly oral care visits where they will have their teeth brushed with a soft bristled toothbrush by the interventionist. No treatment to the oral mucosa will be provided to this group as part of the intervention. Subjects will receive oral care instructions and will be asked to follow SOC oral hygiene instructions at home. Standard of Care Oral Hygiene: Standard of care oral hygiene- weekly oral care visits with soft-bristled toothbrushing.	Oral Mucosal Deterging and Dental Prophylaxis (OMDP) n=30 Participants Oral Mucosal Deterging \& Dental Prophylaxis (OMDP) protocol: Subjects assigned to OMDP will attend weekly intervention visits during which they will have their teeth cleaned and will receive the OMDP intervention as follows: subjects will receive a professional dental prophylaxis including periodontal surface debridement and deterging of the oral mucosal surfaces. Subjects will be asked to follow OMDP oral hygiene instructions at home. Oral mucosal deterging and dental prophylaxis: Subjects will receive a professional dental prophylaxis including periodontal surface debridement \[a light-touch, gentle form of instrumentation performed with an ultrasonic instrument to promote plaque removal, to facilitate biofilm disruption and endotoxin flushing, but yet with the preservation of the periodontal cementum\] and deterging of the oral mucosal surfaces\].
Inflammatory Markers Correlative Measures IL4	7.7 pg/mL Standard Deviation 30.0	-12.7 pg/mL Standard Deviation 34.9
Inflammatory Markers Correlative Measures IL5	2.2 pg/mL Standard Deviation 6.5	0.5 pg/mL Standard Deviation 8.5
Inflammatory Markers Correlative Measures IL1a	53.9 pg/mL Standard Deviation 84.4	50.6 pg/mL Standard Deviation 152.9
Inflammatory Markers Correlative Measures IL1b	30.4 pg/mL Standard Deviation 26.5	13.3 pg/mL Standard Deviation 44.9
Inflammatory Markers Correlative Measures IL2	37.9 pg/mL Standard Deviation 39.2	-64.3 pg/mL Standard Deviation 249.8

SECONDARY outcome

Timeframe: Baseline and visits 1-9 interval during radiation therapy (area under the curve).

OM severity (Grade 3 or more) was measured by a blinded member of the study team using the WHO OTS (previously described) and the duration and time to onset of severe OM measured in days.

Outcome measures

Outcome measures
Measure	Standard of Care Oral Hygiene n=30 Participants Standard of Care Oral Hygiene group (SOC-OH): Subjects assigned to SOC-OH will attend weekly oral care visits where they will have their teeth brushed with a soft bristled toothbrush by the interventionist. No treatment to the oral mucosa will be provided to this group as part of the intervention. Subjects will receive oral care instructions and will be asked to follow SOC oral hygiene instructions at home. Standard of Care Oral Hygiene: Standard of care oral hygiene- weekly oral care visits with soft-bristled toothbrushing.	Oral Mucosal Deterging and Dental Prophylaxis (OMDP) n=30 Participants Oral Mucosal Deterging \& Dental Prophylaxis (OMDP) protocol: Subjects assigned to OMDP will attend weekly intervention visits during which they will have their teeth cleaned and will receive the OMDP intervention as follows: subjects will receive a professional dental prophylaxis including periodontal surface debridement and deterging of the oral mucosal surfaces. Subjects will be asked to follow OMDP oral hygiene instructions at home. Oral mucosal deterging and dental prophylaxis: Subjects will receive a professional dental prophylaxis including periodontal surface debridement \[a light-touch, gentle form of instrumentation performed with an ultrasonic instrument to promote plaque removal, to facilitate biofilm disruption and endotoxin flushing, but yet with the preservation of the periodontal cementum\] and deterging of the oral mucosal surfaces\].
Duration of OM Severity	0.667 weeks Interval 0.125 to 2.056	0.433 weeks Interval 0.052 to 1.61

SECONDARY outcome

Saliva flow rate (mL/minute) from baseline to subsequent visits was assessed by a 5-minute stimulated saliva collection. The outcome analyzed was the change from baseline to subsequent visits in saliva.

Outcome measures

Outcome measures
Measure	Standard of Care Oral Hygiene n=30 Participants Standard of Care Oral Hygiene group (SOC-OH): Subjects assigned to SOC-OH will attend weekly oral care visits where they will have their teeth brushed with a soft bristled toothbrush by the interventionist. No treatment to the oral mucosa will be provided to this group as part of the intervention. Subjects will receive oral care instructions and will be asked to follow SOC oral hygiene instructions at home. Standard of Care Oral Hygiene: Standard of care oral hygiene- weekly oral care visits with soft-bristled toothbrushing.	Oral Mucosal Deterging and Dental Prophylaxis (OMDP) n=30 Participants Oral Mucosal Deterging \& Dental Prophylaxis (OMDP) protocol: Subjects assigned to OMDP will attend weekly intervention visits during which they will have their teeth cleaned and will receive the OMDP intervention as follows: subjects will receive a professional dental prophylaxis including periodontal surface debridement and deterging of the oral mucosal surfaces. Subjects will be asked to follow OMDP oral hygiene instructions at home. Oral mucosal deterging and dental prophylaxis: Subjects will receive a professional dental prophylaxis including periodontal surface debridement \[a light-touch, gentle form of instrumentation performed with an ultrasonic instrument to promote plaque removal, to facilitate biofilm disruption and endotoxin flushing, but yet with the preservation of the periodontal cementum\] and deterging of the oral mucosal surfaces\].
Salivary Hypofunction	-0.878 mL/minute Standard Error 0.0822	-0.821 mL/minute Standard Error 0.0822

SECONDARY outcome

The average pain of OM was measured subjectively (visual analog scale 0-10) and obtained by having subjects complete a questionnaire with questions based on an eleven-point numeric scale regarding oral pain (0 being no pain and 10 being maximum pain).

Outcome measures

Outcome measures
Measure	Standard of Care Oral Hygiene n=30 Participants Standard of Care Oral Hygiene group (SOC-OH): Subjects assigned to SOC-OH will attend weekly oral care visits where they will have their teeth brushed with a soft bristled toothbrush by the interventionist. No treatment to the oral mucosa will be provided to this group as part of the intervention. Subjects will receive oral care instructions and will be asked to follow SOC oral hygiene instructions at home. Standard of Care Oral Hygiene: Standard of care oral hygiene- weekly oral care visits with soft-bristled toothbrushing.	Oral Mucosal Deterging and Dental Prophylaxis (OMDP) n=30 Participants Oral Mucosal Deterging \& Dental Prophylaxis (OMDP) protocol: Subjects assigned to OMDP will attend weekly intervention visits during which they will have their teeth cleaned and will receive the OMDP intervention as follows: subjects will receive a professional dental prophylaxis including periodontal surface debridement and deterging of the oral mucosal surfaces. Subjects will be asked to follow OMDP oral hygiene instructions at home. Oral mucosal deterging and dental prophylaxis: Subjects will receive a professional dental prophylaxis including periodontal surface debridement \[a light-touch, gentle form of instrumentation performed with an ultrasonic instrument to promote plaque removal, to facilitate biofilm disruption and endotoxin flushing, but yet with the preservation of the periodontal cementum\] and deterging of the oral mucosal surfaces\].
Pain Scores	-7.39 0-10 score on a scale Standard Deviation 3.51	5.45 0-10 score on a scale Standard Deviation 3.43

SECONDARY outcome

Quality of life and function was assessed using the validated EORTC-QLQ-C30 for head and neck cancers. This questionnaire assesses general quality of life as well as issues specific to head and neck cancer patients (e.g. difficulty swallowing, pain, dry mouth). The analysis was focused on EORTC-QLC30 Questions 31 through 48. High scores indicate better QOL. High scores for the Sypmton Scale are indicative of deterioration.

Outcome measures

Outcome measures
Measure	Standard of Care Oral Hygiene n=30 Participants Standard of Care Oral Hygiene group (SOC-OH): Subjects assigned to SOC-OH will attend weekly oral care visits where they will have their teeth brushed with a soft bristled toothbrush by the interventionist. No treatment to the oral mucosa will be provided to this group as part of the intervention. Subjects will receive oral care instructions and will be asked to follow SOC oral hygiene instructions at home. Standard of Care Oral Hygiene: Standard of care oral hygiene- weekly oral care visits with soft-bristled toothbrushing.	Oral Mucosal Deterging and Dental Prophylaxis (OMDP) n=30 Participants Oral Mucosal Deterging \& Dental Prophylaxis (OMDP) protocol: Subjects assigned to OMDP will attend weekly intervention visits during which they will have their teeth cleaned and will receive the OMDP intervention as follows: subjects will receive a professional dental prophylaxis including periodontal surface debridement and deterging of the oral mucosal surfaces. Subjects will be asked to follow OMDP oral hygiene instructions at home. Oral mucosal deterging and dental prophylaxis: Subjects will receive a professional dental prophylaxis including periodontal surface debridement \[a light-touch, gentle form of instrumentation performed with an ultrasonic instrument to promote plaque removal, to facilitate biofilm disruption and endotoxin flushing, but yet with the preservation of the periodontal cementum\] and deterging of the oral mucosal surfaces\].
QOL and Function	0.323 0-100 score on a scale Interval 0.152 to 0.494	0.135 0-100 score on a scale Interval -0.0333 to 0.303

Adverse Events

Standard of Care Oral Hygiene

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Oral Mucosal Deterging and Dental Prophylaxis (OMDP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard of Care Oral Hygiene n=30 participants at risk Standard of Care Oral Hygiene group (SOC-OH): Subjects assigned to SOC-OH will attend weekly oral care visits where they will have their teeth brushed with a soft bristled toothbrush by the interventionist. No treatment to the oral mucosa will be provided to this group as part of the intervention. Subjects will receive oral care instructions and will be asked to follow SOC oral hygiene instructions at home. Standard of Care Oral Hygiene: Standard of care oral hygiene- weekly oral care visits with soft-bristled toothbrushing.	Oral Mucosal Deterging and Dental Prophylaxis (OMDP) n=30 participants at risk Oral Mucosal Deterging \& Dental Prophylaxis (OMDP) protocol: Subjects assigned to OMDP will attend weekly intervention visits during which they will have their teeth cleaned and will receive the OMDP intervention as follows: subjects will receive a professional dental prophylaxis including periodontal surface debridement and deterging of the oral mucosal surfaces. Subjects will be asked to follow OMDP oral hygiene instructions at home. Oral mucosal deterging and dental prophylaxis: Subjects will receive a professional dental prophylaxis including periodontal surface debridement \[a light-touch, gentle form of instrumentation performed with an ultrasonic instrument to promote plaque removal, to facilitate biofilm disruption and endotoxin flushing, but yet with the preservation of the periodontal cementum\] and deterging of the oral mucosal surfaces\].
Respiratory, thoracic and mediastinal disorders Pneumonia	3.3% 1/30 • Number of events 1 • Percentages and numbers of participants were used to summarize AEs and SAEs. AEs record all related adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation in source documents. At each study visit, the investigator inquired about the occurrence of AE/SAEs since the last visit. Events were followed for outcome information until resolution or stabilization. Serious Adverse Events: 5 subjects in Arm 1 and 0 subjects in Arm 0 experienced an AE graded as severe. 4 of those AE's were also classified as serious. No serious adverse events were determined to be related to the study treatment and/or procedures.	0.00% 0/30 • Percentages and numbers of participants were used to summarize AEs and SAEs. AEs record all related adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation in source documents. At each study visit, the investigator inquired about the occurrence of AE/SAEs since the last visit. Events were followed for outcome information until resolution or stabilization. Serious Adverse Events: 5 subjects in Arm 1 and 0 subjects in Arm 0 experienced an AE graded as severe. 4 of those AE's were also classified as serious. No serious adverse events were determined to be related to the study treatment and/or procedures.
Hepatobiliary disorders Cholangiocarcinoma	3.3% 1/30 • Number of events 1 • Percentages and numbers of participants were used to summarize AEs and SAEs. AEs record all related adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation in source documents. At each study visit, the investigator inquired about the occurrence of AE/SAEs since the last visit. Events were followed for outcome information until resolution or stabilization. Serious Adverse Events: 5 subjects in Arm 1 and 0 subjects in Arm 0 experienced an AE graded as severe. 4 of those AE's were also classified as serious. No serious adverse events were determined to be related to the study treatment and/or procedures.	0.00% 0/30 • Percentages and numbers of participants were used to summarize AEs and SAEs. AEs record all related adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation in source documents. At each study visit, the investigator inquired about the occurrence of AE/SAEs since the last visit. Events were followed for outcome information until resolution or stabilization. Serious Adverse Events: 5 subjects in Arm 1 and 0 subjects in Arm 0 experienced an AE graded as severe. 4 of those AE's were also classified as serious. No serious adverse events were determined to be related to the study treatment and/or procedures.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neck mass	3.3% 1/30 • Number of events 1 • Percentages and numbers of participants were used to summarize AEs and SAEs. AEs record all related adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation in source documents. At each study visit, the investigator inquired about the occurrence of AE/SAEs since the last visit. Events were followed for outcome information until resolution or stabilization. Serious Adverse Events: 5 subjects in Arm 1 and 0 subjects in Arm 0 experienced an AE graded as severe. 4 of those AE's were also classified as serious. No serious adverse events were determined to be related to the study treatment and/or procedures.	0.00% 0/30 • Percentages and numbers of participants were used to summarize AEs and SAEs. AEs record all related adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation in source documents. At each study visit, the investigator inquired about the occurrence of AE/SAEs since the last visit. Events were followed for outcome information until resolution or stabilization. Serious Adverse Events: 5 subjects in Arm 1 and 0 subjects in Arm 0 experienced an AE graded as severe. 4 of those AE's were also classified as serious. No serious adverse events were determined to be related to the study treatment and/or procedures.
Social circumstances Adult failure to thrive	3.3% 1/30 • Number of events 1 • Percentages and numbers of participants were used to summarize AEs and SAEs. AEs record all related adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation in source documents. At each study visit, the investigator inquired about the occurrence of AE/SAEs since the last visit. Events were followed for outcome information until resolution or stabilization. Serious Adverse Events: 5 subjects in Arm 1 and 0 subjects in Arm 0 experienced an AE graded as severe. 4 of those AE's were also classified as serious. No serious adverse events were determined to be related to the study treatment and/or procedures.	0.00% 0/30 • Percentages and numbers of participants were used to summarize AEs and SAEs. AEs record all related adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation in source documents. At each study visit, the investigator inquired about the occurrence of AE/SAEs since the last visit. Events were followed for outcome information until resolution or stabilization. Serious Adverse Events: 5 subjects in Arm 1 and 0 subjects in Arm 0 experienced an AE graded as severe. 4 of those AE's were also classified as serious. No serious adverse events were determined to be related to the study treatment and/or procedures.
Musculoskeletal and connective tissue disorders Gout acute	3.3% 1/30 • Number of events 1 • Percentages and numbers of participants were used to summarize AEs and SAEs. AEs record all related adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation in source documents. At each study visit, the investigator inquired about the occurrence of AE/SAEs since the last visit. Events were followed for outcome information until resolution or stabilization. Serious Adverse Events: 5 subjects in Arm 1 and 0 subjects in Arm 0 experienced an AE graded as severe. 4 of those AE's were also classified as serious. No serious adverse events were determined to be related to the study treatment and/or procedures.	0.00% 0/30 • Percentages and numbers of participants were used to summarize AEs and SAEs. AEs record all related adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation in source documents. At each study visit, the investigator inquired about the occurrence of AE/SAEs since the last visit. Events were followed for outcome information until resolution or stabilization. Serious Adverse Events: 5 subjects in Arm 1 and 0 subjects in Arm 0 experienced an AE graded as severe. 4 of those AE's were also classified as serious. No serious adverse events were determined to be related to the study treatment and/or procedures.

Other adverse events

Adverse event data not reported

Additional Information

Associate Vice Chancelor, Clinical Trials Operations

University of Pittsburgh

Phone: 412-383-2561

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place