Commensal Oral Microbiota in Head and Neck Cancer

NCT ID: NCT03843554

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-23
• Study Completion Date: 2022-08-03

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.

Detailed Description

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.

Conditions

Head and Neck Cancer; Oral Mucositis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Standard of Care Oral Hygiene

Intervention Type: OTHER

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.

Group Type: EXPERIMENTAL

Oral mucosal deterging and dental prophylaxis

Intervention Type: 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.

Interventions

Standard of Care Oral Hygiene

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

Intervention Type: OTHER

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

To participate in this study, an individual must meet all the following criteria:

1. 18 years of age or older;

2. Able and willing to provide informed consent prior to initiation of study procedures;

3. Scheduled to undergo radiation or chemoradiation treatment for head/neck cancer;

4. 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.

5. Presents with a minimum of 6 natural teeth.

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Pregnant or lactating at the baseline/screening visit;

2. Participating in another oral health interventional research study at any point during their participation in this trial;

3. Receiving induction chemotherapy or concurrent radiation therapy with cetuximab;

4. Reports current use of antifungal or antibiotic at the time of enrollment;

5. Presents with immunocompromised status (defined as an absolute neutrophil count (ANC) of less than 1000);

6. 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:

1. prosthetic cardiac valves, including transcatheter-implanted prostheses and homografts;

2. prosthetic material used for cardiac valve repair, such as annuloplasty rings and chords;

3. a history of infective endocarditis;

4. a cardiac transplant with valve regurgitation due to a structurally abnormal valve;

5. 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;

7. 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;

8. Presents with severe periodontal disease for which treatment cannot be completed prior to the start of radiation/chemoradiation (at the discretion of the investigator);

9. Had surgery as part of cancer treatment and is not sufficiently healed to comply with study requirements prior to RT initiation;

10. 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: collaborator

The Forsyth Institute

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Patricia Corby, DDS

Associate Dean of Translational Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia Corby, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Alex Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Penn Medicine, Perelman Center for Advanced Medicine

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U01DE027637

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UPCC 06319

Identifier Type: OTHER

Identifier Source: secondary_id

832750

Identifier Type: -

Identifier Source: org_study_id