An observational study in Oral Complications of Chemotherapy and Head and Neck Radiation, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-02-14.
Sponsored by Cairo University · Observational
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
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
Cairo University is the lead sponsor of 4,911 studies on the registry; 1,443 are open to participants now.
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patients who are diagnosed with head and neck cancer and started their chemo and radiotherapy treatment
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
by ESAS questionnaire ,clinical examination of the patient
questionnaire is answered by the patient
Time frame: through study completion, an average of 1 year
oral mucositis assessed by WHO(world Health Organization) scale, clinical examination
grade(A)none , (I)mild ,(II)moderate (III)severe and( life threatening (B) 1 asymptomatic or mild pain,2moderate,3 severe,4 life threatening
Time frame: through study completion, an average of 1 year
xerostomia by CODs (Clinical oral dryness scale)
questionnaire completed with added clinical examination scored from 1-3indicate mild dryness then 4-6 moderate dryness and 8-10 severe dryness
Time frame: through study completion, an average of 1 year
dysphagia by VHNSS Version 2.0 (Vanderbilt Head and Neck Cancer Symptom Survey)
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).
Time frame: through study completion, an average of 1 year
pain assessed by numerical rating scale(NRS)
from 0 indicating no pain to 10 being worst pain
Time frame: through study completion, an average of 1 year
quality of life assessment QOL-Version 4(Washington University Quality Of Life ) questionnaire
questionnaire consists of 12 single question domains, these having between 3 and 6 response options that are scaled evenly from 0 (worst) to 100 (best) according to the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety
Time frame: through study completion, an average of 1 year
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2020 to primary completion in Feb 2022, 16 months.
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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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