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临床试验/NCT04845854
NCT04845854已完成不适用

Prevalence of Oral Side Effects Associated With Chemo and Radiotherapy for Treating Head and Neck Cancer: a Cross-sectional Study

Cairo University1 个研究点 分布在 1 个国家目标入组 294 人开始时间: 2020年10月2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
294
试验地点
1
主要终点
by ESAS questionnaire ,clinical examination of the patient

研究概览

简要总结

A cross-sectional study will be conducted to report oral complications during chemo and radiotherapy treatment in case of patients diagnosed with head and neck cancer and the effect of theses oral side effects on patients' quality of life which will in turn allow the implication of preventive measures

详细描述

the primary out come of this study is to report oral side effects associated with chemo and radiotherapy used for treating head and neck cancer .patient will be enrolled and data will be collected from the national institute of cancer in Egypt. this will be done through filling the modified ( Edmonton Symptom Assessment System) ESAS questionnaire used to asses different oral side effects in cancer patients. history taking and Clinical examination will be done for each patient enrolled in the study after obtaining their consent form by the main investigator. each and every oral manifestations will be measured by a specific scale . the secondary outcome is identified as the assessment of the effect of oral complications on patients' quality of life which will be determined through completing UW-QOL(University of Washington-Quality Of Life) questionnaire version 4.during the study, patient , treatment and tumor variable will be considered and documented .Data collected form the patient and or from medical records will be saved and tabulated on computer for back up and finally statistically analyzed. A power analysis was designed to have adequate power to apply a statistical test of the research question regarding the degree to which oral adverse events can prevail among patients receiving chemotherapy or radiotherapy. According to the results of Minhas, Sadia, et al. -in which prevalence of oral adverse events was (92.6%)- and by adopting a confidence interval of (95%), a margin of error of (3%) with finite population correction; the predicted sample size (n) was a total of (292) cases. Sample size calculation was performed using Epi info for windows version 7.2

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients after the first week of their treatment till the end of their treatment protocol and at their follow-up visits
  • patients who completed ESAS questioner
  • Male and female patients from 20 -70 years old who are diagnosed with head and neck cancer.

排除标准

  • Patients who didn't start their treatment before the examination
  • Patients who refuse to participate in the study.
  • Patients with leukemia or blood cell cancers, infants and children

结局指标

主要结局

by ESAS questionnaire ,clinical examination of the patient

时间窗: through study completion, an average of 1 year

questionnaire is answered by the patient

oral mucositis assessed by WHO(world Health Organization) scale, clinical examination

时间窗: through study completion, an average of 1 year

grade(A)none , (I)mild ,(II)moderate (III)severe and( life threatening (B) 1 asymptomatic or mild pain,2moderate,3 severe,4 life threatening

dysphagia by VHNSS Version 2.0 (Vanderbilt Head and Neck Cancer Symptom Survey)

时间窗: through study completion, an average of 1 year

assess the severity of dysphagia by a questionnaire related to struggle during swallowing ,xerostomia, nutrition deficiency ,mucous secretion or taste changes ,mucositis and speech affection each scored from 0 (none) to 10 (severe).

xerostomia by CODs (Clinical oral dryness scale)

时间窗: through study completion, an average of 1 year

questionnaire completed with added clinical examination scored from 1-3indicate mild dryness then 4-6 moderate dryness and 8-10 severe dryness

pain assessed by numerical rating scale(NRS)

时间窗: through study completion, an average of 1 year

from 0 indicating no pain to 10 being worst pain

次要结局

  • quality of life assessment QOL-Version 4(Washington University Quality Of Life ) questionnaire(through study completion, an average of 1 year)

研究者

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

Dalia Mohamed abo el -fadel

post graduation student

Cairo University

研究点 (1)

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