Clinical trial NCT04845854: Prevalence of Oral Side Effects Associated With Chemo and Radiotherapy for Treating Head and Neck Cancer
Official title: Prevalence of Oral Side Effects Associated With Chemo and Radiotherapy for Treating Head and Neck Cancer: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Complications of Chemotherapy and Head and Neck Radiation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 294
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients who are diagnosed with head and neck cancer and started their chemo and radiotherapy treatment

Brief summary: 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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: by ESAS questionnaire ,clinical examination of the patient
timeFrame: through study completion, an average of 1 year
measure: oral mucositis assessed by WHO(world Health Organization) scale, clinical examination
timeFrame: through study completion, an average of 1 year
measure: xerostomia by CODs (Clinical oral dryness scale)
timeFrame: through study completion, an average of 1 year
measure: dysphagia by VHNSS Version 2.0 (Vanderbilt Head and Neck Cancer Symptom Survey)
timeFrame: through study completion, an average of 1 year
measure: pain assessed by numerical rating scale(NRS)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: quality of life assessment QOL-Version 4(Washington University Quality Of Life ) questionnaire
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Institute of Cancer in Egypt
Study officials:
affiliation: dentist at hospital specialized centers
name: dalia m abo el fadel, master
role: PRINCIPAL_INVESTIGATOR
References: