NCT06901401Active, not recruiting
Oral Health-Related Quality of Life Using EORTC QLQ-H&N35 in Head and Neck Cancer Survivors Within the First Year Following Treatment: a Cross-Sectional Study in Egypt
Source: ClinicalTrials.gov · Last updated 28 Mar 2025
Brief summary (registry, in English)
This study aims to evaluate Oral Health-Related Quality of Life (OHRQoL) in head and neck cancer (HNC) survivors within the first year following treatment in Egypt. Using a cross-sectional study design, data will be collected from patients at Ahmed Maher Teaching Hospital (AMTH) through structured questionnaires and clinical assessments, including the Arabic version of EORTC QLQ-H\&N35, oral hygiene index-simplified (OHI-S), and the WHO Oral Mucositis Scale. The study will examine the association between OHRQoL and various factors, including sociodemographic characteristics, oral hygiene practices, and clinical parameters such as oral mucositis severity. A sample size of 112 participants was determined using a one-sample t-test, ensuring adequate statistical power while accounting for a 20% dropout rate. Findings from this research will help highlight the impact of HNC treatment on oral health and provide insights into improving oral care strategies for better patient quality of life in Egypt.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 112 (estimated)
- First submitted
- 23 Mar 2025
- Start date
- 15 Oct 2024
- Primary completion date
- 15 Apr 2025
- Lead sponsor
- Ain Shams University
- Diseases
- Head and neck cancer
- NCT number
- NCT06901401
What you commit to
- Study type: Observational
- Planned participants: 112
- From 15 Oct 2024 to the primary completion date, 15 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with cognitive impairment or severe mental illness affecting their ability to respond to the questionnaire.
- Patients with debilitating conditions (e.g., terminal illness, bedridden status).
Other
- Trismus (mouth opening \<20mm) preventing oral examination.
- Patients who decline to participate or withdraw consent.
- Patients with incomplete medical records or loss to follow-up.
Who the study is looking for
- (HNC).
- Completed cancer treatment (surgery, radiotherapy, and/or chemotherapy) within the past 12 months.
- Attending routine follow-up visits at Ahmed Maher Teaching Hospital (AMTH), Egypt.
- Able to communicate and complete the EORTC QLQ-H\&N35 questionnaire.
- Presence of at least one molar and one central incisor in both upper and lower dentition (for oral hygiene assessment).
- Provided written informed consent to participate in the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ahmed Maher Teaching Hospital Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
Related publications
- Oral health-related quality of life in head and neck cancer survivors in Egypt within the first year after radiotherapy: a multivariable analysis.BMC Oral Health · 2025 · PMID 41454361
This page is information, not medical advice. Discuss any trial with your doctor.