Ozone Therapy for the Treatment of Oral Mucositis in Patients Undergoing Radio and Chemotherapy in the Head and Neck Region: Retrospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- WHO scale for oral mucositis
研究概览
简要总结
The present study aims to evaluate the effectiveness of a combined protocol of professional and at-home ozone therapy in the treatment of oral mucositis in patients undergoing radio- and/or chemotherapy.
In-office treatment was performed using a medical ozone generator, while at-home therapy involved the daily application of high-concentration ozonated oil products. The study assessed the reduction in mucositis severity (WHO scale), decrease in pain (VAS scale), and improvement in patient-reported quality of life, with specific attention to nutrition, oral hygiene, and treatment adherence.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing radio and chemotherapy for head and neck cancer and cancers in other districts
排除标准
- •syndromic patients
- •pregnant women
- •patients with cardiac pacemakers
- •epileptic patients
- •patients with high sensitivity to electric current
研究组 & 干预措施
Patients undergoing radio and chemotherapy for head and neck cancer
干预措施: Ozone treatment (Device)
Patients undergoing radio and chemotherapy for cancers in other districts
干预措施: Ozone treatment (Device)
结局指标
主要结局
WHO scale for oral mucositis
时间窗: At baseline (T0), baseline after treatment (T1), after 48 hours (T2), at day five (T3), at day eight (T4), at day twelve (T5), at day fifteen (T6)
Scoring criteria: * 0 None * 1 Oral soreness, erythema * 2 Oral erythema, ulcers, solid diet tolerated * 3 Oral ulcers, liquid diet only
次要结局
- Visual Analogue Scale(At baseline (T0), baseline after treatment (T1), after 48 hours (T2), at day five (T3), at day eight (T4), at day twelve (T5), at day fifteen (T6))
- Questionnaire(At baseline (T0) and at day fifteen (T6))
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia