Oral Complications of Chemotherapy and Head and Neck RadiationNCT04845854
Prevalence of Oral Side Effects Associated With Chemo and Radiotherapy for Treating Head and Neck Cancer
An observational study of Oral Complications of Chemotherapy and Head and Neck Radiation, run by Cairo University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Oral Complications of Chemotherapy and Head and Neck Radiation
- How many people
- 294 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Oct 2020to 3 Sep 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Adult, Older adult
Study population: patients who are diagnosed with head and neck cancer and started their chemo and radiotherapy treatment
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
What is being measured
The primary outcome is the main question the study is designed to answer.
by ESAS questionnaire ,clinical examination of the patient
questionnaire is answered by the patient
Measured: 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
Measured: 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
Measured: 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).
Measured: 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
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start2 Oct 2020
- Primary completion20 Feb 2022
- Study completion3 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Complications of Chemotherapy and Head and Neck RadiationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 294 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Mohamed abo el -fadel, Cairo University
- Investigators
- dalia m abo el fadel, master, Principal investigator, dentist at hospital specialized centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845854
- Sponsor's protocol ID
- 4221
- Status last verified
- Apr 2021
- First submitted
- 7 Apr 2021
- Last updated
- 14 Feb 2023
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Oral Side Effects Associated With Chemo and Radiotherapy for Treating Head and Neck Cancer: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04845854
- Acronym / sponsor ID
- 4221
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 20 Feb 2022 (actual)
- Study completion
- 3 Sep 2022 (actual)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients who are diagnosed with head and neck cancer and started their chemo and radiotherapy treatment
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
by ESAS questionnaire ,clinical examination of the patient
Time frame: through study completion, an average of 1 year
questionnaire is answered by the patient
oral mucositis assessed by WHO(world Health Organization) scale, clinical examination
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
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
dysphagia by VHNSS Version 2.0 (Vanderbilt Head and Neck Cancer Symptom Survey)
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).
pain assessed by numerical rating scale(NRS)
Time frame: through study completion, an average of 1 year
from 0 indicating no pain to 10 being worst pain
1 secondary outcome
quality of life assessment QOL-Version 4(Washington University Quality Of Life ) questionnaire
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Oral Complications of Chemotherapy and Head and Neck Radiation
Not yet recruitingObservational study
Retrospective Observational Study of Oral Complications and Quality of Life in Head and Neck Cancer Patients Treated With Radiotherapy or Chemoradiotherapy.
Oral Mucositis, Quality of Life
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
dalia m abo el fadel, master principal investigator
dentist at hospital specialized centers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Complications of Chemotherapy and Head and Neck Radiation, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
by ESAS questionnaire ,clinical examination of the patient (time frame: through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.