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

Official title

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

Overview

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.

Detailed description

Oral mucositis is a frequent and clinically significant side effect of radiotherapy for head and neck cancer. While mucosal injury is primarily related to radiation exposure, additional biological factors may influence the onset and severity of this condition. Reactivation of viruses from the Herpesviridae family has been suggested as a potential contributing factor, but existing evidence is limited and inconsistent. There is currently no standard preventive antiviral strategy for oral mucositis in this population.

This study is designed to characterize the presence and changes of herpesviruses in the oral cavity of adults undergoing radiotherapy for head and neck cancer and to evaluate whether prophylactic antiviral treatment affects viral detection and clinical outcomes related to oral mucositis. The trial uses a randomized, double-blind, placebo-controlled design to reduce bias and allow for an objective assessment of antiviral prophylaxis.

Participants receive either oral valacyclovir or matching placebo during the course of radiotherapy. Oral and saliva samples are collected at predefined time points before the start of radiotherapy, during treatment, and after completion of radiotherapy. These samples are analyzed to detect and quantify human herpesviruses using molecular methods. Clinical assessments of the oral cavity are performed regularly to evaluate the presence and severity of oral mucositis, and patient-reported pain is monitored throughout treatment.

The study aims to describe the pattern of herpesvirus detection in the oral cavity over time and to explore associations between viral presence, mucositis severity, and pain. In addition, the study evaluates whether antiviral prophylaxis influences these outcomes when compared with placebo.

By improving the understanding of the relationship between herpesvirus activity and oral mucositis, this study may inform future preventive or supportive care strategies for patients receiving radiotherapy for head and neck cancer.

Interventions

• Drug Valacyclovir
  Valacyclovir is administered orally during the course of radiotherapy for head and neck cancer as a prophylactic antiviral intervention.
• Drug Placebo
  A matching placebo is administered orally during the course of radiotherapy for head and neck cancer.

Primary outcome measures

• Severity of Oral Mucositis [Time frame: From start of radiotherapy (day 1) until 2 weeks after completion of radiotherapy.]

Secondary outcome measures (1)

• Incidence of Ulcerative Oral Mucositis [Time frame: From start of radiotherapy (Day 1) until 2 weeks after completion of radiotherapy.]

Eligibility criteria

Inclusion criteria

• 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 criteria

• Known hypersensitivity or contraindication to valacyclovir or related antiviral agents.
• Current or recent use of systemic antiviral therapy.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Supportive care

Study locations

Brazil · 1 center

• Instituto Oncoclinicas — Rio de Janeiro

Identifiers

NCT: NCT07363031 · 56941822.3.0000.5134

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗