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

Sponsor
Instituto Oncoclinicas
Study ID
NCT07363031
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 5, 2022
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Valacyclovir
    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.
  • Placebo Comparator: Placebo
    Participants in this arm receive a matching placebo during radiotherapy for head and neck cancer for comparison with the valacyclovir group.

Primary Outcome Measure

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

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