Efficacy of Laser Therapy and Ozone Therapy for the Treatment of Oral Mucositis in Cancer Patients: A Randomized Clinical Trial
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 by WHO Oral Mucositis Scale
研究概览
简要总结
This randomized clinical trial aims to compare the efficacy of laser therapy and ozone therapy in the treatment of oral mucositis in adult cancer patients undergoing chemotherapy or radiotherapy, particularly those with head and neck tumors or hematologic malignancies. Oral mucositis is a frequent and debilitating complication of cancer treatment, characterized by painful ulcerations that impair nutrition, speech, and oral hygiene, often requiring opioid analgesics and supportive care.
Forty eligible patients will be randomly assigned to two parallel groups. The trial group will receive high-power diode laser therapy using a flat-top handpiece at 660 nm wavelength, following a standardized photobiomodulation protocol. The control group will be treated with medical ozone gas administered via an intraoral device, using a standardized ozone therapy protocol. Both treatments will be applied once daily over five consecutive days. Patients will be followed up at 15 and 30 days after treatment initiation.
The primary outcome is the reduction in mucositis severity, measured using the World Health Organization (WHO) Oral Toxicity Scale. Secondary outcomes include pain intensity assessed with the Visual Analogue Scale (VAS), and quality of life evaluated through the Oral Mucositis Weekly Questionnaire - Head and Neck (OMWQ-HN). The study seeks to determine whether laser therapy offers superior clinical benefits compared to ozone therapy in reducing lesion severity, alleviating pain, and improving patient well-being during cancer treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥18 years
- •Diagnosis of head and neck cancer or hematologic malignancy
- •Currently undergoing chemotherapy and/or radiotherapy
- •Presence of oral mucositis of grade 2 or higher (WHO Oral Mucositis Scale)
- •Ability to provide written informed consent
- •Willingness to comply with study procedures and follow-up schedule
排除标准
- •Presence of autoimmune or systemic diseases affecting the oral mucosa (e.g., lichen planus, pemphigus, pemphigoid)
- •Presence of active oral infections unrelated to mucositis (e.g., candidiasis, herpes simplex)
- •Previous treatment with ozone or laser therapy for oral mucositis in the past 3 months
- •Pregnancy or breastfeeding
- •Cognitive impairment or psychiatric disorders preventing full cooperation
- •Known allergy or intolerance to ozone or laser exposure
- •Use of investigational drugs or participation in other clinical trials within 30 days prior to enrollment
研究组 & 干预措施
Laser Therapy for Oral Mucositis
Patients in this arm will undergo high-power diode laser therapy using the Garda Laser LEO PLUS device with a flat-top handpiece at a wavelength of 660 nm. The laser is applied intraorally on the mucosal lesions following a standardized photobiomodulation protocol. The treatment is administered once daily for five consecutive days. Mucositis severity (WHO scale), pain intensity (VAS), and quality of life (OMWQ-HN) will be monitored from baseline through 30 days of follow-up.
干预措施: Laser Therapy (Device)
Ozone Therapy for Oral Mucositis
Patients in this arm will receive medical ozone therapy for the treatment of chemotherapy- or radiotherapy-induced oral mucositis. Ozone is administered intraorally in gaseous form using a Sweden & Martina DTA device and a flat probe specifically designed for mucosal application. The treatment is delivered once daily for five consecutive days, following a standardized therapeutic protocol. Clinical parameters including mucositis severity (WHO scale), pain (VAS), and quality of life (OMWQ-HN) will be assessed at baseline and during follow-up.
干预措施: Ozone therapy (Device)
结局指标
主要结局
Change in Oral Mucositis Severity Assessed by WHO Oral Mucositis Scale
时间窗: Baseline (T0), Day 5 (T1), Day 15 (T3), and Day 30 (T5)
Oral mucositis severity will be evaluated using the World Health Organization (WHO) Oral Mucositis Scale, a standardized clinical tool that grades mucosal toxicity on a scale from 0 to 4. Grade 0 indicates no mucositis, grade 1 indicates soreness and erythema, grade 2 denotes erythema and ulcers but the patient can eat solid food, grade 3 represents ulcers with a liquid diet only, and grade 4 corresponds to severe mucositis with alimentation not possible. Scores will be recorded at baseline (T0), after 5 days of treatment (T1), and at follow-up visits on day 15 (T3) and day 30 (T5). The primary endpoint is the change in WHO score from baseline to day 30.
次要结局
- Change in Pain Intensity Assessed by Visual Analogue Scale (VAS)(Baseline (T0), Day 5 (T1), Day 15 (T3), and Day 30 (T5))
- Change in Quality of Life Assessed by Oral Mucositis Weekly Questionnaire - Head and Neck (OMWQ-HN)(Baseline (T0), Day 5 (T1), Day 15 (T3), and Day 30 (T5))
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia