- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04845854
Prevalence of Oral Side Effects Associated With Chemo and Radiotherapy for Treating Head and Neck Cancer
February 11, 2023 updated by: Dalia Mohamed abo el -fadel, Cairo University
Prevalence of Oral Side Effects Associated With Chemo and Radiotherapy for Treating Head and Neck Cancer: a Cross-sectional Study
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
Study Overview
Status
Completed
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
Study Type
Observational
Enrollment (Actual)
294
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cairo, Egypt
- National Institute of Cancer in Egypt
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients who are diagnosed with head and neck cancer and started their chemo and radiotherapy treatment
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
by ESAS questionnaire ,clinical examination of the patient
Time Frame: through study completion, an average of 1 year
|
questionnaire is answered by the patient
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through study completion, an average of 1 year
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oral mucositis assessed by WHO(world Health Organization) scale, clinical examination
Time Frame: through study completion, an average of 1 year
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grade(A)none , (I)mild ,(II)moderate (III)severe and( life threatening (B) 1 asymptomatic or mild pain,2moderate,3 severe,4 life threatening
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through study completion, an average of 1 year
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xerostomia by CODs (Clinical oral dryness scale)
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
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through study completion, an average of 1 year
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dysphagia by VHNSS Version 2.0 (Vanderbilt Head and Neck Cancer Symptom Survey)
Time Frame: through study completion, an average of 1 year
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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).
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through study completion, an average of 1 year
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pain assessed by numerical rating scale(NRS)
Time Frame: through study completion, an average of 1 year
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from 0 indicating no pain to 10 being worst pain
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through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
quality of life assessment QOL-Version 4(Washington University Quality Of Life ) questionnaire
Time Frame: through study completion, an average of 1 year
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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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: dalia m abo el fadel, master, dentist at hospital specialized centers
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 2, 2020
Primary Completion (ACTUAL)
February 20, 2022
Study Completion (ACTUAL)
September 3, 2022
Study Registration Dates
First Submitted
April 7, 2021
First Submitted That Met QC Criteria
April 14, 2021
First Posted (ACTUAL)
April 15, 2021
Study Record Updates
Last Update Posted (ESTIMATE)
February 14, 2023
Last Update Submitted That Met QC Criteria
February 11, 2023
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4221
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Oral Complications of Chemotherapy and Head and Neck Radiation
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Wake Forest University Health SciencesCompletedHead and Neck Cancer | Radiation Toxicity | Radiation-Induced Xerostomia | Oral Complications of Chemotherapy and Head/Neck RadiationUnited States
-
A.T. Still University of Health SciencesCompletedDental Caries | Oral Cavity Cancer | Oral Complications of Chemotherapy and Head/Neck RadiationUnited States
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National Cancer Institute (NCI)UnknownHead and Neck Cancer | Radiation Toxicity | Oral Complications of Radiation TherapyUnited States
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Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedHead and Neck Cancer | Radiation Toxicity | Dysgeusia | Oral Complications
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NeoMedLightMonitoring Force GroupCompletedHead and Neck Cancer | Oral Mucositis (Ulcerative) Due to Radiation | Radiation Therapy ComplicationGermany
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Radiation Therapy Oncology GroupNational Cancer Institute (NCI)CompletedHead and Neck Cancer | Radiation Toxicity | Oral Complications of Radiation TherapyUnited States
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University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedHead and Neck Cancer | Radiation Toxicity | Long-term Effects Secondary to Cancer Therapy in Adults | Oral Complications of Radiation Therapy
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Mashhad University of Medical SciencesCompletedRadiation-induced Mucositis of Oral Mucous MembranesIran, Islamic Republic of
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University Hospital Schleswig-HolsteinUnknownRadiation Dermatitis | Radiation-induced Oral MucositisGermany, Spain
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