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

NCT07363031 | Enrolling By Invitation Phase 2

• 1 other identifier: 56941822.3.0000.5134
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Mucositis; Head and Neck Cancer (H&N); Radiotherapy Side Effects

Keywords

Oral Mucositis; Head and Neck Cancer; Radiotherapy; Herpesviridae; Herpesvirus reactivation; Valacyclovir; Antiviral prophylaxis; Oral toxicity; Supportive care in oncology; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Severity of Oral Mucositis

  Maximum oral mucositis severity assessed using the World Health Organization (WHO) Oral Mucositis Grading Scale, which ranges from 0 (no mucositis) to 4 (severe mucositis). Higher scores indicate worse oral mucositis severity.

  From start of radiotherapy (day 1) until 2 weeks after completion of radiotherapy.

Secondary Outcomes (1)

• Incidence of Ulcerative Oral Mucositis

  From start of radiotherapy (Day 1) until 2 weeks after completion of radiotherapy.

Other Outcomes (2)

• Oral Pain Intensity

  From start of radiotherapy (Day 1) until 2 weeks after completion of radiotherapy.

• Oral Herpesvirus Detection and Viral Load Over Time

  From start of radiotherapy (Day 1), weekly during radiotherapy, and 1 month after completion of radiotherapy (approximately up to 12 weeks).

Study Arms (2)

Valacyclovir

EXPERIMENTAL

Participants in this arm receive oral valacyclovir during radiotherapy for head and neck cancer to evaluate its effect on oral herpesvirus detection and oral mucositis outcomes.

Drug: Valacyclovir

Placebo

PLACEBO COMPARATOR

Participants in this arm receive a matching placebo during radiotherapy for head and neck cancer for comparison with the valacyclovir group.

Drug: Placebo

Interventions

Valacyclovir DRUG

Valacyclovir is administered orally during the course of radiotherapy for head and neck cancer as a prophylactic antiviral intervention.

Valacyclovir

Placebo DRUG

A matching placebo is administered orally during the course of radiotherapy for head and neck cancer.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Oncoclinicas: lead
• Oswaldo Cruz Foundation: collaborator
• Hospital Sírio-Libânes, São Paulo, Brazil: collaborator

Study Sites (1)

Instituto Oncoclinicas

Rio de Janeiro, Rio de Janeiro, 22250-905, Brazil

Location

MeSH Terms

Conditions

Stomatitis; Head and Neck Neoplasms

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, healthcare providers, investigators, and outcome assessors are blinded to treatment allocation. Valacyclovir and placebo are identical in appearance and administration, and treatment assignment is concealed until completion of data analysis or in the event of a medical emergency requiring unblinding.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to one of two parallel groups to receive either prophylactic valacyclovir or placebo during radiotherapy for head and neck cancer. Each participant remains in the assigned group for the duration of the study.

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 23, 2026
• Study Start: September 5, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: De-identified individual participant data and the study protocol will be available beginning after publication of the primary study results and will remain available for up to 5 years following publication.
• Access Criteria: Access to de-identified individual participant data and the study protocol will be provided to qualified researchers upon reasonable request. Requests will be reviewed by the study investigators and subject to approval by the sponsoring institution, execution of a data use agreement, and compliance with ethical and regulatory requirements. Only data necessary to achieve the approved research objectives will be shared.

Locations

BR (1)