Commensal Oral Microbiota in Head and Neck Cancer

NCT03843554 | Terminated Results DMC

• 3 other identifiers: 832750U01DE027637UPCC 06319
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer; Oral Mucositis

Keywords

Head Cancer; Neck Cancer; Oral Mucositis; Oral Health; Radiation; Chemoradiation

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (5)

• Inflammatory Markers Correlative Measures

  Baseline and final intervention visit.

• Duration of OM Severity

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

• Salivary Hypofunction

  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

  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

  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).

Study Arms (2)

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.

Other: Standard of Care Oral Hygiene

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.

Procedure: Oral mucosal deterging and dental prophylaxis

Interventions

Standard of Care Oral Hygiene OTHER

Standard of care oral hygiene- weekly oral care visits with soft-bristled toothbrushing.

Standard of Care Oral Hygiene

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.

Oral Mucosal Deterging and Dental Prophylaxis (OMDP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To participate in this study, an individual must meet all the following criteria:
• years of age or older;
• Able and willing to provide informed consent prior to initiation of study procedures;
• Scheduled to undergo radiation or chemoradiation treatment for head/neck cancer;
• Presents with at least one of nine areas of the oral or oropharyngeal mucosa (i.e., upper lip, lower lip, right cheek, left cheek, right ventral and lateral tongue, left ventral and lateral tongue, floor of the mouth, and soft palate) expected to receive at least 5000 cGy of RT. Patients with cancer located outside of the oral cavity will be included when at least 5000 cGy of RT will be administered to the oral cavity in addition to the RT targeted at the primary cancer site.
• Presents with a minimum of 6 natural teeth.

You may not qualify if:

• 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:
• prosthetic cardiac valves, including transcatheter-implanted prostheses and homografts;
• prosthetic material used for cardiac valve repair, such as annuloplasty rings and chords;
• a history of infective endocarditis;
• a cardiac transplant with valve regurgitation due to a structurally abnormal valve;
• the following congenital (present from birth) heart disease: unrepaired cyanotic congenital heart disease, including palliative shunts and conduits; or any repaired congenital heart defect with residual shunts or valvular regurgitation at the site of or adjacent to the site of a prosthetic patch or a prosthetic device;
• 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;

Sponsors & Collaborators

• University of Pennsylvania: lead
• NYU Langone Health: collaborator
• The Forsyth Institute: collaborator
• Medical University of South Carolina: collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Stomatitis

Interventions

Dental Prophylaxis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Periodontics; Dentistry; Preventive Dentistry

Limitations and Caveats

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.

Results Point of Contact

• Title: Associate Vice Chancelor, Clinical Trials Operations
• Organization: University of Pittsburgh

pat.corby@pitt.edu

412-383-2561

Study Officials

• Patricia Corby, DDS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Alex Lin, MD

  Penn Medicine, Perelman Center for Advanced Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessors will grade the oral mucositis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean of Translational Research

Model Details: Prospective, single blind, two arm, randomized, controlled trial

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 18, 2019
• Study Start: September 23, 2019
• Primary Completion: August 3, 2022
• Study Completion: August 3, 2022
• Last Updated: September 26, 2025
• Results First Posted: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)