Evaluation of Low Level Diode Diode Versus Topical Chamomile in Management of Chemotherapy Induced Oral Mucositis: Three Arm Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- Discomfort and pain
研究概览
简要总结
a three-arm head-to-head randomized clinical trial assessing two of the promising studied interventions, low-level diode laser and topical Chamomile, comparing them to each other's and to conventional therapy in the management of oral mucositis-induced chemotherapy.
详细描述
The latest MASCC/ISOO Mucositis Guidelines recommend relieving pain, reducing inflammation, and preventing secondary infection as the main pillars in the management of chemotherapy-induced oral mucositis. Accordingly, our comparator will be conventional therapy, including topical anti-inflammatory, topical analgesic, and topical antifungal.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
Double-blinded trial:
The outcome assessor and the statistician will be blinded. Participants can't be blinded because of the difference in intervention methods of application.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ibuprofen oral gel and miconazole oral gel
One group will receive conventional oral therapy composed of topical ibuprofen oral gel as an anti-inflammatory and analgesic and topical miconazole as an anti-fungal oral gel.
干预措施: Ibuprofen analgesic and anti-inflammatory oral gel and miconazole anti fungal oral gel (Drug)
low-level diode laser diode laser
The second group will receive a diode laser with a wave length range of 800-980 nm and power less than 500 ml.
干预措施: Low level diode laser (Device)
Chamomile
The third group will receive chamomile 3% mucoadhesive gel.
干预措施: Chamomile (Drug)
结局指标
主要结局
Discomfort and pain
时间窗: On baseline, first, third, fifth, seventh, tenth and 14th day.
Reported by each patient using the Visual Analog Scale (0-10),10 refers to maximum pain
次要结局
- Oral mucositis severity(On baseline, first, third, fifth, seventh, tenth and 14th day.)
- The total healing time of oral ulcers(On baseline, first, third, fifth, seventh, tenth and 14th day.)
研究者
Clair Sobhy Nagieb Botros
Oral medicine specialist
Cairo University