Clinical trial · Interventional
Commensal Oral Microbiota in Head and Neck Cancer
The ARMOR Trial: Commensal Oral Microbiota as a Trigger of Oral Mucositis Severity
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral mucosal deterging and dental prophylaxis | Procedure | — | UNRESOLVED |
| Standard of Care Oral Hygiene | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Standard of Care Oral Hygiene
- description
- 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.
- interventionNames
- Other: Standard of Care Oral Hygiene
- type
- EXPERIMENTAL
- label
- Oral Mucosal Deterging and Dental Prophylaxis (OMDP)
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: 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. Subject 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).
References
Publications (0)
Data not yet available