NCT07363031Enrolling by invitationPhase 2
Oral Herpesviruses and Oral Mucositis in Patients Receiving Head and Neck Radiotherapy
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
Source: ClinicalTrials.gov · Last updated 23 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 8 Jan 2026
- Start date
- 5 Sept 2022
- Primary completion date
- Jun 2026
- Lead sponsor
- Instituto Oncoclinicas
- Diseases
- Head and neck cancer
- NCT number
- NCT07363031
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 84
- From 5 Sept 2022 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or recent use of systemic antiviral therapy.
Other illness
- 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.
Other
- Pregnant or breastfeeding individuals.
- Participation in another interventional clinical trial that may interfere with study outcomes.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Oncoclinicas Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.