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临床试验/NCT05181943
NCT05181943已完成不适用

EFFECTIVNESS OF PHOTO BIO-MODULATION IN THE TREATMENT OF CHEMOTHERAPY INDUCED ORAL MUCOSITIS IN CHILDREN WITH ACUTE LEUKEMIA Randomized Controlled Clinical Trial

Alexandria University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2020年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Self-reported pain level

研究概览

简要总结

The aim of the current study was to study the effect of diode laser in the treatment of chemotherapy induced mucositis in young patients suffering from leukemia

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
Single (Outcomes Assessor)

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • children diagnosed with mucositis and receiving chemotherapy

排除标准

  • 未提供

研究组 & 干预措施

Laser irradiation (Test group)

Experimental

laser irradiation over lesion

干预措施: Simpler diode laser (Device)

Conventional treatment (Control group

Active Comparator

干预措施: Conventional symptomatic treatment (Drug)

结局指标

主要结局

Self-reported pain level

时间窗: up to 2 weeks

Participants were asked to report the degree of pain. This was assessed using the visual analogue scale (VAS) which ranges from zero (lowest score) to 10 (highest score). Higher scores indicate higher pain level.

Oral mucositis lesion size

时间窗: up to 2 weeks

This was assessed using the World Health Organization oral mucositis lesion score Grade 0: no oral mucositis. Grade1: Presence of soreness and erythema. Grade 2: Presence of painful erythema and ulcerations that do not affect the patient solid food intake. Grade3: Confluent ulceration that affect the solid food intake and require liquid diet. Grade 4: The patient requires parenteral nutrition.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Farida Reayd

Instructor of Oral Medicine

Alexandria University

研究点 (1)

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