Clinical Trial

Oral Herpesviruses and Oral Mucositis in Patients Receiving Head and Neck Radiotherapy

Enrolling by Invitation Phase 2
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Record status
This record was last updated January 23, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Summary
Patients receiving radiotherapy for head and neck cancer often develop oral mucositis, a painful condition that causes redness and sores in the mouth. Oral mucositis can make it difficult to eat, drink, and speak, and may interfere with cancer treatment. Some viruses from the herpesvirus family, which commonly remain inactive in the body, may become active during cancer treatment and worsen mouth sores. However, the role of these viruses in oral mucositis is not fully understood. This study aims to understand whether herpesviruses present in the mouth are associated with the development and severity of oral mucositis in adults receiving radiotherapy for head and neck cancer. The study also evaluates whether taking an antiviral medication (valacyclovir) can reduce viral activity and improve mouth symptoms during treatment. Participants are randomly assigned to receive either valacyclovir or a placebo while undergoing radiotherapy. Samples from the mouth and saliva are collected at different time points before, during, and after radiotherapy to detect herpesviruses. Mouth sores are regularly examined, and pain levels are recorded throughout treatment. The results of this study may help clarify the role of herpesviruses in oral mucositis and support better strategies to prevent or manage this condition in patients receiving radiotherapy for head and neck cancer.
Trial Details
NCT Number NCT07363031
Lead Sponsor Instituto Oncoclinicas
Collaborators: Oswaldo Cruz Foundation, Hospital Sirio-Libanes
Conditions Oral Mucositis, Head and Neck Cancer (H&N), Radiotherapy Side Effects
Enrollment 84 participants
Start Date 2022-09-05
Primary Completion 2026-06 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2026-01-23