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临床试验/NCT04493879
NCT04493879已完成不适用

Efficacy of Bioptron Light Therapy (BLT) on Post Chemotherapy Oral Mucositis

Cairo University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Oral Ulceration

研究概览

简要总结

The study aimed to study the effect of Bioptron light therapy (BLT) on oral mucositis after receiving chemotherapy in patients with head and neck cancer,Oral mucositis (OM) is a common and severe acute side-effect of many oncologic treatments, especially in patients treated for head and neck cancer. It affects quality of life and require supportive care and proper treatment plane.

This study had been conducted on thirty cancer patients (head &neck) receiving chemotherapy & radiotherapy (males and females) with oral mucositis with ulceration and pain(grade 2 and more), their age ranged from 35 to 55 years, capable of understanding the study assessment method and willing to complete the current study, they were free from any immunodeficiency disorders or diseases that could impair the healing process and impact the results as diabetes mellitus. Patients were randomly allocated from patients from the National Cancer Institute, Cairo University. Group A (BLT group): This group consisted of 15 patients receiving BLT for about 10 minutes every day for thirty days in addition to routine oral mucositis medical care (Analgesics, anti-inflammatory treatment and antimicrobial treatment for any new mouth infections), Group B (Control group): This group consisted of 15 patients receiving daily routine oral mucositis medical care(Analgesics, anti-inflammatory treatment and antimicrobial treatment for any new mouth infections) for thirty days The methods of evaluation in the current study were the WHO oral mucositis scale (OMS) and the Common toxicity criteria scale (CTCS). At the same time, the treatment equipment was the polarized light therapy device Bioptron Compact III (PAG-860 manufactured in Switzerland) Assessment by WHO oral mucositis scale and (OMS) and (CTCS) were used before treatment and after treatment to measure improvement in oral mucositis.

The results of WHO oral mucositis scale (OMS) and the Common toxicity criteria scale (CTCS) were assessed first at the beginning of the study and one month after the end of the study; calculation of mean, standard deviation, minimum and maximum for each group was done by descriptive statistics, means comparison between the two groups pre and post-application and within each group was made using The t-test. With a level of significance Alpha point of 0.05

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 (Participant)

入排标准

年龄范围
35 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Cancer patients (head &neck) receiving chemotherapy & radiotherapy
  • Males and females
  • Age ranged from 35-55 years
  • All patients capable of understanding the study assessment method and willing to complete the current study
  • Patients free from any immunodeficiency disorders or diseases that could impair the healing process and impact the results as diabetes .

排除标准

  • Patients suffering from immunodeficiency disorders or diseases that could impair the healing process and impact the results as diabetes .
  • Cognitive impairment

结局指标

主要结局

Oral Ulceration

时间窗: 30 days

WHO oral mucositis scale (OMS) and the Common toxicity criteria scale (CTCS)

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

Marwa Eid

assistant professor of physical therapy for surgery

Cairo University

研究点 (2)

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