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| ID | Type | Description | Link |
|---|---|---|---|
| U01DE027637 | U.S. NIH Grant/Contract | View source | |
| UPCC 06319 | Other Identifier | University of Pennsylvania Cancer Center |
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Study was terminated with 50% enrollment by the sponsor due to under enrollment into specific diverse racial, ethnic, and sex/gender categories.
https://grants.nih.gov/policy/inclusion/women-and-minorities.htm
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| Name | Class |
|---|---|
| NYU Langone Health | OTHER |
| The Forsyth Institute | OTHER |
| Medical University of South Carolina | OTHER |
| National Institute of Dental and Craniofacial Research (NIDCR) |
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The ARMOR Trial will test the efficacy of an oral care protocol to treat oral mucositis (OM) in patients receiving radiation (RT) or chemoradiation (chemoRT) for head and neck cancer. Participants will attend a screening/baseline visit, weekly intervention visits while they are undergoing RT or chemoRT, and a visit 3 months after completing RT or chemoRT. At intervention visits, samples will be collected (such as saliva, oral swabs) and participants will receive their assigned study intervention, either Oral Mucosal Deterging and Dental Prophylaxis protocol (OMDP), which includes a dental cleaning and treatment to the oral mucosa, or a Standard of Care Oral Hygiene, which includes teeth brushing and no treatment to the oral mucosa.
This is a prospective, single blind, two arm, randomized, controlled trial to test the efficacy of an oral care protocol to treat oral mucositis (OM) in patients receiving radiation (RT) or chemoradiation (chemoRT) for head and neck cancer. This trial will also measure salivary proinflammatory cytokines, and evaluate other clinical effects of the intervention during cancer therapy. In addition, oral mucosal swabs will be collected for the future characterization of changes in the microbiome associated with OM severity.
Patients will be randomized in a 1:1 ratio to two different oral care protocols within 4 strata defined by type of RT (Proton beam therapy (Protons)) vs intensity-modulated radiation therapy (IMRT) and cancer treatment (RT versus chemoRT). Eligible subjects will be assigned to receive either the Oral Mucosal Deterging and Dental Prophylaxis protocol (OMDP) or a Standard of Care Oral Hygiene protocol (SOC-OH). Prior to randomization, all enrolled subjects will receive a baseline dental prophylaxis and fluoride varnish application prior to start of RT or chemoRT to ensure that all subjects enter the study with comparable oral health. Subjects assigned to OMDP will receive the OMDP Protocol (Oral Mucosal Deterging and Dental Prophylaxis) at weekly intervention visits. Subjects randomized to the SOC-OH will receive oral health instructions following the American Dental Association Guidelines and will have their teeth cleaned (brushed) during weekly intervention visits; no treatment to the oral mucosa will be provided to this group.
At each bi-weekly study visit, study assessments will include the collection of saliva and oral mucosal swabs, an oral exam and OM assessment, and the completion of questionnaires. During the course of the study, subjects will attend one baseline visit, up to 9 intervention visits, and a follow-up visit approximately 3 months after completion of RT. Local supportive care, including normal saline rinses, topical anesthetics, mixed medication mouthwashes (e.g. Magic Mouthwash), feeding tubes, and pain management will be allowed according to each recruitment site's standard of care procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Oral Hygiene | Placebo Comparator | 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. |
|
| Oral Mucosal Deterging and Dental Prophylaxis (OMDP) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care Oral Hygiene | Other | Standard of care oral hygiene- weekly oral care visits with soft-bristled toothbrushing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oral Mucosal Severity (Grade 3 or 4) | 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). | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory Markers Correlative Measures | 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. | Baseline and final intervention visit. |
| Duration of OM Severity |
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Currently enrolling subjects receiving intensity-modulated radiation therapy (IMRT), with or without chemotherapy.
Subject Inclusion Criteria
To participate in this study, an individual must meet all the following criteria:
Subject Exclusion Criteria
An individual who meets any of the following criteria will be excluded from participation in this study:
Pregnant or lactating at the baseline/screening visit;
Participating in another oral health interventional research study at any point during their participation in this trial;
Receiving induction chemotherapy or concurrent radiation therapy with cetuximab;
Reports current use of antifungal or antibiotic at the time of enrollment;
Presents with immunocompromised status (defined as an absolute neutrophil count (ANC) of less than 1000);
Presents with any of the following conditions, which based on American Dental and American College of Cardiology guidelines, require antibiotic prophylaxis prior to dental treatment:
Presents with cardiovascular implantable electronic devices (CIEDs) such as pacemakers, and implantable cardioverter-defibrillators; unless, a) in the opinion of the investigator, the OMDP protocol can be performed with hand scalers (and not with an ultrasonic device as per protocol) or upon consult with the treating cardiologist, it is determined that the ultrasonic device can be safely used;
Presents with severe periodontal disease for which treatment cannot be completed prior to the start of radiation/chemoradiation (at the discretion of the investigator);
Had surgery as part of cancer treatment and is not sufficiently healed to comply with study requirements prior to RT initiation;
In the opinion of the investigator, is unable or unlikely to comply fully with the study requirements or procedures for any reason (e.g. cognitive or physical impairment).
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Corby, DDS | University of Pennsylvania | Principal Investigator |
| Alex Lin, MD | Penn Medicine, Perelman Center for Advanced Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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]. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
ARMOR Trial employed a two-arm (OMDP vs STANDARD) parallel group design. Data were available on 30 subjects in each arm who received IMRT treatment (n=60). Baseline characteristics and demographics were presented for all 60 randomized subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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. |
| 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 Mucosal Severity (Grade 3 or 4) | 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). | 60 randomized subjects, 30 per arm. | Posted | Count of Participants | Participants | 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). |
|
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.
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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 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | SNOMED CT | Systematic Assessment | Initial or prolonged hospitalization |
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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 NIDCR/DSMB recommended to discontinue enrollment in the Proton arm. The trial was terminated on 08/31/22. Study was terminated with 50% enrollment by the sponsor due to -under enrollment into specific diverse racial, ethnic, and sex/gender categories. Only IMRT cases were used for analyses.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Vice Chancelor, Clinical Trials Operations | University of Pittsburgh | 412-383-2561 | pat.corby@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 4, 2022 | Feb 28, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 4, 2022 | Feb 28, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D003777 | Dental Prophylaxis |
| ID | Term |
|---|---|
| D010517 | Periodontics |
| D003813 | Dentistry |
| D011313 | Preventive Dentistry |
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| NIH |
Prospective, single blind, two arm, randomized, controlled trial
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Blinded assessors will grade the oral mucositis.
| Oral mucosal deterging and dental prophylaxis | Procedure | 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. |
|
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. |
| Baseline and visits 1-9 interval during radiation therapy (area under the curve). |
| Salivary Hypofunction | 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. | 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). |
| Pain Scores | 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). | 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). |
| QOL and Function | 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. | 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). |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | 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. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | 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. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | 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. | Count of Participants | Participants |
|
| Race (NIH/OMB) | 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. | Count of Participants | Participants |
|
| OG001 | 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]. |
|
|
|
| Secondary | Inflammatory Markers Correlative Measures | 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. | 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). | Posted | Mean | Standard Deviation | pg/mL | Baseline and final intervention visit. |
|
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|
|
| Secondary | Duration of OM Severity | 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. | Posted | Mean | 95% Confidence Interval | weeks | Baseline and visits 1-9 interval during radiation therapy (area under the curve). |
|
|
|
|
| Secondary | Salivary Hypofunction | 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. | Posted | Least Squares Mean | Standard Error | mL/minute | 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). |
|
|
|
|
| Secondary | Pain Scores | 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). | Posted | Mean | Standard Deviation | 0-10 score on a scale | 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). |
|
|
|
|
| Secondary | QOL and Function | 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. | Posted | Least Squares Mean | 95% Confidence Interval | 0-100 score on a scale | 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). |
|
|
|
|
| 0 |
| 30 |
| 5 |
| 30 |
| 0 |
| 30 |
| EG001 | 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]. | 0 | 30 | 0 | 30 | 0 | 30 |
|
| Cholangiocarcinoma | Hepatobiliary disorders | SNOMED CT | Systematic Assessment |
|
| Neck mass | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | SNOMED CT | Systematic Assessment |
|
| Adult failure to thrive | Social circumstances | SNOMED CT | Systematic Assessment | Initial or prolonged hospitalization |
|
| Gout acute | Musculoskeletal and connective tissue disorders | SNOMED CT | Systematic Assessment |
|
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| IL2 |
|
| IL4 |
|
| IL5 |
|
| The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t- test was used to compare the change in inflammatory markers between the two groups. | t-test, 2 sided | 0.3510 | IL1b | Mean Difference (Final Values) | -17.1 | Standard Error of the Mean | 52.1 | 2-Sided | 95 | Superiority | OMDP-STANDARD |
| The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t- test was used to compare the change in inflammatory markers between the two groups. | t-test, 2 sided | 0.3510 | IL2 | Mean Difference (Final Values) | -102.2 | Standard Error of the Mean | 252.8 | 2-Sided | 95 | Superiority | OMDP-STANDARD |
| The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t- test was used to compare the change in inflammatory markers between the two groups. | t-test, 2 sided | 0.8371 | Mean Difference (Final Values) | -20.4 | Standard Error of the Mean | 46.0 | 2-Sided | 95 | Superiority | IL4 |
| The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t- test was used to compare the change in inflammatory markers between the two groups. | t-test, 2 sided | 0.2991 | Mean Difference (Final Values) | -1.7 | Standard Error of the Mean | 10.7 | 2-Sided | 95 | Superiority | IL5 |
OMDP-STANDARD