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ENROLLING BY INVITATION
NCT07363031
PHASE2

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

Sponsor: Instituto Oncoclinicas

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2022-09-05

Completion Date

2026-10

Last Updated

2026-01-23

Healthy Volunteers

No

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.

Locations (1)

Instituto Oncoclinicas

Rio de Janeiro, Rio de Janeiro, Brazil