Oral MucositisPhase 2NCT07363031
Oral Herpesviruses and Oral Mucositis in Patients Receiving Head and Neck Radiotherapy
A Phase 2 study testing Valacyclovir in people with Oral Mucositis and Head and Neck Cancer (H&N), run by Instituto Oncoclinicas at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis, Head and Neck Cancer (H&N), Radiotherapy Side Effects
- What is being tested?
- Valacyclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Sep 2022to Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- Valacyclovir, Placebo
- Keywords
- Oral Mucositis, Head and Neck Cancer, Radiotherapy, Herpesviridae, Herpesvirus reactivation, Valacyclovir, Antiviral prophylaxis, Oral toxicity, Supportive care in oncology, Randomized controlled trial
- Medical subject headings
- Stomatitis, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValacyclovirDrug
Valacyclovir is administered orally during the course of radiotherapy for head and neck cancer as a prophylactic antiviral intervention.
PlaceboDrug
A matching placebo is administered orally during the course of radiotherapy for head and neck cancer.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From start of radiotherapy (day 1) until 2 weeks after completion of radiotherapy.
Secondary outcomes (1)
Incidence of Ulcerative Oral Mucositis
Proportion of participants who develop ulcerative oral mucositis (World Health Organization [WHO] Oral Mucositis Grading Scale grade ≥ 2) during radiotherapy. The WHO Oral Mucositis Grading Scale ranges from 0 (no mucositis) to 4 (severe mucositis), with higher scores indicating worse oral mucositis severity.
Measured: From start of radiotherapy (Day 1) until 2 weeks after completion of radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start5 Sep 2022
- Primary completionJun 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Oncoclinicas
- Sponsor type
- University, hospital or other
- Collaborators
- Oswaldo Cruz Foundation, Hospital Sirio-Libanes
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363031
- Sponsor's protocol ID
- 56941822.3.0000.5134
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results of this study will be made available upon reasonable request. Requests will be reviewed by the study investigators and subject to institutional approvals and data sharing agreements, in accordance with ethical and regulatory requirements.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07363031
- Acronym / sponsor ID
- 56941822.3.0000.5134
- Keywords
- Oral Mucositis, Head and Neck Cancer, Radiotherapy, Herpesviridae, Herpesvirus reactivation, Valacyclovir, Antiviral prophylaxis, Oral toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Instituto OncoclinicasUniversity, hospital or other
- Collaborators
- Oswaldo Cruz Foundation, Hospital Sirio-Libanes
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Valacyclovir | Experimental | Drug: ValacyclovirParticipants 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 | Placebo comparator | Drug: PlaceboParticipants in this arm receive a matching placebo during radiotherapy for head and neck cancer for comparison with the valacyclovir group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ValacyclovirValacyclovir is administered orally during the course of radiotherapy for head and neck cancer as a prophylactic antiviral intervention. | Drug | Valacyclovir |
| PlaceboA matching placebo is administered orally during the course of radiotherapy for head and neck cancer. | Drug | Placebo |
Primary outcome
Severity of Oral Mucositis
Time frame: From start of radiotherapy (day 1) until 2 weeks after completion of radiotherapy.
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.
1 secondary outcome
Incidence of Ulcerative Oral Mucositis
Time frame: From start of radiotherapy (Day 1) until 2 weeks after completion of radiotherapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results of this study will be made available upon reasonable request. Requests will be reviewed by the study investigators and subject to institutional approvals and data sharing agreements, in accordance with ethical and regulatory requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Valacyclovir in people with Oral Mucositis and Head and Neck Cancer (H&N), run by Instituto Oncoclinicas at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Oral Mucositis (time frame: From start of radiotherapy (day 1) until 2 weeks after completion of radiotherapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.