Clinical Outcomes of Laser Therapy Versus Ozone Therapy for Oral Mucositis in Patients With Cancer: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Oral Mucositis Severity Assessed Using the World Health Organization Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Oral Mucositis Severity Assessed Using the World Health Organization Scale
时间窗: 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.
次要结局
- 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 Mucositis-Related Quality of Life Assessed Using the OMWQ-HN(At baseline before the first treatment session (T0) and 30 days after T0 (T5).)
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia