Oral Mucositis
Conditions
Keywords
Oral Mucositis, Laser Therapy, Photobiomodulation, Ozone Therapy, Cancer Patients, Chemotherapy, Radiotherapy, Pain, World Health Organization Oral Mucositis Scale, Visual Analogue Scale
Brief summary
This retrospective observational study will compare laser therapy and ozone therapy for the management of oral mucositis in adults with head and neck cancer. Oral mucositis is a painful inflammation of the mouth that may develop during radiotherapy, chemotherapy, or concurrent chemoradiotherapy and can cause redness, ulceration, difficulty eating or swallowing, and reduced quality of life. The study will review existing clinical records of patients who previously received either laser therapy or ozone therapy as part of routine clinical care. Patients were not assigned to treatment by the study protocol, and no additional treatment or study procedures will be performed. The main outcome will be the change in oral mucositis severity measured using the World Health Organization oral mucositis scale. Secondary outcomes will include changes in oral pain measured using a visual analogue scale and changes in oral mucositis-related quality of life, when questionnaire data are available. The aim is to determine whether the clinical course of oral mucositis differs between patients treated with laser therapy and those treated with ozone therapy.
Detailed description
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.
Interventions
DEVICELaser Therapy
Adult patients in this cohort previously received diode laser therapy for oral mucositis as part of routine clinical care. Treatment was delivered to the affected oral mucosa using a diode laser device. Available medical records will be reviewed to retrieve treatment parameters, including wavelength, power, energy, application time, number of treated sites, treatment frequency, and number of sessions, when documented. No laser treatment will be assigned or administered as part of this retrospective study.
DEVICEOzone therapy
Adult patients in this cohort previously received topical gaseous ozone therapy for oral mucositis as part of routine clinical care. Ozone was applied to the affected oral mucosa using an intraoral ozone-generating device and a dedicated probe. Available medical records will be reviewed to retrieve treatment parameters, including device settings, application duration, treated sites, treatment frequency, and number of sessions, when documented. No ozone treatment will be assigned or administered as part of this retrospective study.
Sponsors
University of Pavia
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oral Mucositis Severity Assessed Using the World Health Organization Scale | At baseline before the first treatment session (T0), 24 hours after T0 (T1), 48 hours after T0 (T2), 5 days after T0 (T3), 15 days after T0 (T4), and 30 days after T0 (T5). | Change in oral mucositis severity from baseline to the last available follow-up assessment will be evaluated using the World Health Organization Oral Toxicity Scale. The scale ranges from grade 0 to grade 4, where grade 0 indicates no oral mucositis and grade 4 indicates severe mucositis with inability to eat or drink. Scores documented in the clinical records will be compared between patients who received laser therapy and those who received ozone therapy. A reduction in the WHO grade indicates clinical improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oral Pain Intensity Assessed Using the Visual Analogue Scale | At baseline before the first treatment session (T0), 24 hours after T0 (T1), 48 hours after T0 (T2), 5 days after T0 (T3), 15 days after T0 (T4), and 30 days after T0 (T5). | Change in oral pain intensity from baseline to each available follow-up assessment will be evaluated using the Visual Analogue Scale. Pain is scored from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores documented in the clinical records will be compared between patients who received laser therapy and those who received ozone therapy. A reduction in the Visual Analogue Scale score indicates an improvement in pain. |
| Change in Oral Mucositis-Related Quality of Life Assessed Using the OMWQ-HN | At baseline before the first treatment session (T0) and 30 days after T0 (T5). | Change in oral mucositis-related quality of life will be assessed using the Oral Mucositis Weekly Questionnaire-Head and Neck. The questionnaire evaluates the impact of oral mucositis on symptoms, oral function, eating, swallowing, and daily activities. Total scores documented in the clinical records will be compared between patients who received laser therapy and those who received ozone therapy. Lower scores indicate a lower impact of oral mucositis and an improvement in quality of life. |
Countries
Italy
Outcome results
None listed