National Institute of Cancer in Egypt
Cairo, Egypt
NCT Number: NCT04845854
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
Looking for future studies?
Notify Me20 year–70 year
All sexes
Observational
Cairo, Egypt
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
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: through study completion, an average of 1 year
questionnaire is answered by the patient
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: through study completion, an average of 1 year
from 0 indicating no pain to 10 being worst pain
Time frame: through study completion, an average of 1 year
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
Cairo University
Other
Prevalence of Oral Side Effects Associated With Chemo and Radiotherapy for Treating Head and Neck Cancer: a Cross-sectional Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.