Laser Therapy Versus Ozone Therapy for Oral Mucositis in Patients With Cancer

This single-center retrospective observational cohort study will evaluate existing clinical records of adults with histologically confirmed head and neck cancer who developed oral mucositis during radiotherapy, chemotherapy, or concurrent chemoradiotherapy.

Patients will be classified according to the treatment previously received for oral mucositis as part of routine clinical care: laser therapy or ozone therapy. Treatment selection occurred independently of the present study. No participant will be assigned to an intervention, and no additional treatment, visit, or research-specific procedure will be performed.

The study will examine the clinical course of oral mucositis using data already documented in medical records. The primary analysis will compare changes in oral mucositis severity, assessed using the World Health Organization Oral Toxicity Scale, between the two cohorts. Secondary analyses will compare changes in oral pain intensity measured using a Visual Analogue Scale and changes in oral mucositis-related quality of life using the Oral Mucositis Weekly Questionnaire-Head and Neck, when these data are available.

Demographic and clinical variables relevant to oral mucositis outcomes may also be extracted, including age, sex, cancer diagnosis, anticancer treatment, baseline mucositis severity, treatment timing, and available follow-up assessments. The analysis will account for the retrospective nature of the study and the availability and completeness of routinely collected clinical data.

Inclusion criteria

• Adults aged 18 years or older.
• Histologically confirmed diagnosis of a malignant neoplasm of the head and neck region.
• Receipt of radiotherapy, chemotherapy, or concurrent chemoradiotherapy for head and neck cancer.
• Clinically documented oral mucositis of World Health Organization grade 1 or higher.
• Previous treatment of oral mucositis with either laser therapy or ozone therapy as part of routine clinical care.
• Availability of baseline oral mucositis severity assessment and at least one post-treatment assessment.
• Availability of sufficient clinical records to determine eligibility and evaluate the study outcomes.

Exclusion criteria

• Active oral infection at the time of oral mucositis assessment, including oral candidiasis or herpes simplex infection.
• Use of another specific treatment for oral mucositis within the 2 weeks before initiation of laser therapy or ozone therapy, when documented.
• Medical conditions contraindicating laser therapy or ozone therapy, including photosensitivity disorders or severe respiratory disease.
• Concurrent participation in another interventional clinical study that could have affected oral mucositis outcomes.
• Pregnancy or breastfeeding at the time of treatment, when documented.
• Neurological, psychiatric, or cognitive conditions that could have impaired reliable pain assessment or questionnaire completion.
• Previous treatment with both laser therapy and ozone therapy during the same episode of oral mucositis.
• Incomplete or insufficient clinical records for assessment of the primary outcome.