Studies a antiviral drug and viruses in mouth sores during head and neck radiotherapy
Tests valacyclovir against placebo in adults having radiotherapy for head and neck cancer.
Plain-language title generated from the registry record
Registry title: Oral Herpesviruses and Oral Mucositis in Patients Receiving Head and Neck Radiotherapy
Key facts
- Where
- Rio de Janeiro, BrazilSee the site
- Phase
- Phase 2
Where in Brazil
- Instituto OncoclinicasRio de Janeiro, BrazilNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Instituto Oncoclinicas
- Trial code
- NCT07363031
- Record updated
- 23 January 2026
- Original description
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.Read full original descriptionShow less
Characterization of the Herpesviridae Family in the Oral Cavity and Its Association With Oral Mucositis in Adult Patients Undergoing Head and Neck Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Prophylactic Valacyclovir
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.
Inclusion: Adults aged 18 years or older; Diagnosis of head and neck cancer; Planned to receive curative or definitive radiotherapy to the head and neck region; Ability to swallow oral medication; Adequate clinical condition to participate in study procedures; Ability to provide written informed consent.
Exclusion: Current or recent use of systemic antiviral therapy; Known hypersensitivity or contraindication to valacyclovir or related antiviral agents; Severe renal impairment requiring dose adjustment or contraindicating valacyclovir use; Active oral infection requiring systemic antimicrobial treatment at baseline; Pregnant or breastfeeding individuals; Participation in another interventional clinical trial that may interfere with study outcomes.