Prevalence of Oral Side Effects Associated With Chemo and Radiotherapy for Treating Head and Neck Cancer

Oral Complications of Chemotherapy and Head and Neck Radiation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04845854
• Other study ID #: 4221
• Status: Completed
• Start date: October 2, 2020
• Est. completion date: September 3, 2022

Study information

• Verified date: April 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: September 3, 2022
• Est. primary completion date: February 20, 2022
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Oral Complications of Chemotherapy and Head and Neck Radiation

Locations

Country	Name	City	State
Egypt	National Institute of Cancer in Egypt	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	by ESAS questionnaire ,clinical examination of the patient	questionnaire is answered by the patient	through study completion, an average of 1 year
Primary	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	through study completion, an average of 1 year
Primary	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	through study completion, an average of 1 year
Primary	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).	through study completion, an average of 1 year
Primary	pain assessed by numerical rating scale(NRS)	from 0 indicating no pain to 10 being worst pain	through study completion, an average of 1 year
Secondary	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	through study completion, an average of 1 year