Trial results for a study investigating an oral care protocol for Head and Neck Cancer patients were posted on ClinicalTrials.gov on 2025-09-26, involving 60 participants.
Background
Head and Neck Cancer treatments, particularly radiation therapy (RT) or chemoradiation (chemoRT), frequently lead to oral mucositis (OM). This painful inflammation of the mucous membranes in the mouth can significantly impact a patient's quality of life, leading to difficulties with eating, speaking, and an increased risk of infection. Managing oral mucositis is a critical supportive care aspect for patients undergoing these cancer therapies, aiming to reduce discomfort and prevent treatment interruptions.
Trial design
The ARMOR Trial (NCT03843554), which was TERMINATED, was designed to test the efficacy of an oral care protocol for oral mucositis in patients receiving radiation or chemoradiation for Head and Neck Cancer. This Phase NA study enrolled 60 participants with Head and Neck Cancer and Oral Mucositis. Participants were assigned to either a Standard of Care Oral Hygiene group or an Oral Mucosal Deterging and Dental Prophylaxis (OMDP) protocol. The study aimed to assess oral mucosal severity and inflammatory markers.
Key results
The trial reported the following key measurements:
- Oral Mucosal Severity (Grade 3 or 4):
- In the Standard of Care Oral Hygiene group, 9 participants experienced Grade 3 or 4 oral mucositis.
- In the Oral Mucosal Deterging and Dental Prophylaxis (OMDP) group, 8 participants experienced Grade 3 or 4 oral mucositis.
- A Fisher Exact analysis comparing these groups yielded a p-value of 0.999.
- Inflammatory Markers Correlative Measures (mean change from baseline to final intervention visit, in pg/mL):
- For the first marker, the Standard of Care Oral Hygiene group had a mean of 53.9 (Standard Deviation 84.4), while the Oral Mucosal Deterging and Dental Prophylaxis (OMDP) group had a mean of 50.6 (Standard Deviation 152.9). The mean difference was -3.3, with a t-test p-value of 0.6336.
- For a second marker, the Standard of Care Oral Hygiene group had a mean of 30.4 (Standard Deviation 26.5), and the Oral Mucosal Deterging and Dental Prophylaxis (OMDP) group had a mean of 13.3 (Standard Deviation 44.9). The mean difference was -17.1, with a t-test p-value of 0.351.
- For a third marker, the Standard of Care Oral Hygiene group had a mean of 37.9 (Standard Deviation 39.2), and the Oral Mucosal Deterging and Dental Prophylaxis (OMDP) group had a mean of -64.3 (Standard Deviation 249.8). The mean difference was -102.2, with a t-test p-value of 0.351.
- For a fourth marker, the Standard of Care Oral Hygiene group had a mean of 7.7 (Standard Deviation 30.0), and the Oral Mucosal Deterging and Dental Prophylaxis (OMDP) group had a mean of -12.7 (Standard Deviation 34.9). The mean difference was -20.4, with a t-test p-value of 0.8371.
- For a fifth marker, the Standard of Care Oral Hygiene group had a mean of 2.2 (Standard Deviation 6.5), and the Oral Mucosal Deterging and Dental Prophylaxis (OMDP) group had a mean of 0.5 (Standard Deviation 8.5). The mean difference was -1.7, with a t-test p-value of 0.2991.
What this means
The results from this terminated trial suggest that the Oral Mucosal Deterging and Dental Prophylaxis (OMDP) protocol did not significantly reduce the incidence of severe (Grade 3 or 4) oral mucositis compared to standard oral hygiene in Head and Neck Cancer patients. While there was a slight numerical reduction in participants experiencing severe mucositis in the OMDP group (8 vs. 9), the statistical analysis showed no significant difference (p-value of 0.999). Similarly, the measured inflammatory markers showed inconsistent changes and lacked statistical significance across the groups. These findings indicate that the tested oral care protocol, as implemented in this study, did not demonstrate a clear benefit over standard care for preventing or mitigating severe oral mucositis or influencing inflammatory responses in this patient population.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03843554, titled "Commensal Oral Microbiota in Head and Neck Cancer", were posted on 2025-09-26 on clinicaltrials.gov.