Head and Neck CncerNCT06901401
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
An observational study of Head and Neck Cncer, run by Ain Shams University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cncer
- Type of treatment
- Pill or oral medicine
- How many people
- 112 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2024to 15 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include adult head and neck cancer (HNC) survivors who have completed surgery, radiotherapy, and/or chemotherapy within the past 12 months. Participants will be recruited from the oncology unit at Ahmed Maher Teaching Hospital (AMTH) in Egypt during their routine follow-up visits. The study population will consist of individuals aged 18 years and older, representing diverse sociodemographic backgrounds. Eligibility criteria include patients who can communicate and complete the EORTC QLQ-H\&N35 questionnaire, as well as those with at least one molar and one central incisor in both upper and lower dentition for oral hygiene assessment. Patients with cognitive impairments, severe debilitating conditions, or trismus (mouth opening <20mm) will be excluded. This study aims to evaluate the impact of cancer treatment on oral health-related quality of life (OHRQoL) and identify factors affecting post-treatment oral health outcomes in Egyptian HNC survivors.
Who may be able to join
- (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.
Who cannot join
- 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).
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Head and neck cancer (HNC) is the seventh most common cancer globally, accounting for more than 660,000 new cases and 325,000 deaths annually. The number of HNC cases is expected to grow by 30% each year until 2030.[1] The rise has been observed in both developed and developing countries.[2] The survival for HNC has improved modestly over the past three decades with the introduction of different and multi-disciplinary treatment modalities.[3] There are several treatment options for HNC, including radiation therapy, surgery, and chemotherapy. These treatments can be used alone or in combination. Radiation therapy (RT) involves using high-energy beams to destroy cancer cells, while it is an important part of HNC treatment, it can also cause various toxicities, sometimes severe, toxicities.[4].
In most of the cases, head and neck tumors may destroy organs that play an important part in daily activities such as eating and speaking [5]. Additionally, the therapeutic approaches for the treatment of cancer usually result in collateral effects [6]. that impact in the quality of life. The assessment of the quality of life in patients with cancer became a valuable tool to investigate the progression of the disease and the effectiveness of the treatment [7].
The oral condition has an essential role in the individual's systemic health [8]. In specific, the quality of lifer elated to oral health (OHRQoL) may be defined as the lack of negative impact of the oral condition on social, psychological and functional activities [9]. In general, patients with tumors in the oral cavity figure amongst the worst indices for the quality of life when compared to patients with tumors in other regions [10]. Based on the exposed, the present study aimed to measure the impact of OHRQoL of patients with HNC and to evaluate the factors associated.
QoL assessment is an important tool for evaluating not only the impact of disease and its treatment on an individual level but also helpful in developing and revising the rehabilitative ser- vices and patient education material to further improve the clinical outcomes (survival) of patients [11]. Oral health related quality of life (OHRQoL), specifically focuses on self-report aspects pertaining to oral health, capturing the functional, social, and psychological dimensions affected by oral disease [12]. In the case of HNC, disruptions in key oral functions poses a higher risk of adversely affecting both OHRQoL and overall QoL[13].
Not much evidence is found in Egypt related to oral care measures for HNC patients, such as professional care by a dentist and dental hygienist (mechanical or manual removal of mucosal debris, oral hygiene counsel- ling, etc.) at least once a week until the completion of RT [14]. The patients are often unaware of the potential harm from the cancer treatment, only a proportion of HNC patients seek dental consultation for their complications, and most of them suffer greatly even after the completion of treatment due to disturbed oral functions.
To the best of our knowledge, this study represents the first comprehensive assessment of OHRQoL in HNC treated patients who had completed their cancer treatment within the past 12 months. Additionally, it aims to explore the associations between various oral clinical parameters, including oral hygiene status and oral mucositis, and several predictive factors such as sociodemographic characteristics and treatment-related variables in relation to OHRQoL. The findings of this study will highlights the importance of standardizing oral care and improving oral health support for HNC treated patients to reduce the impact of oral problems which can negatively impact their overall quality of life.
- Conditions
- Head and Neck Cncer
- Keywords
- Oral Health-Related Quality of Life (OHRQoL), Head and Neck Cancer (HNC), EORTC QLQ-H&N35
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HNC Survivors' Oral Health and Quality of Life in Egypt | This cohort includes head and neck cancer (HNC) survivors within the first year post-treatment at Ahmed Maher Teaching Hospital (AMTH) in Egypt. The study evaluates Oral Health-Related Quality of Life (OHRQoL) using the EORTC QLQ-H\&N35 questionnaire, along with clinical assessments like the Oral Hygiene Index-Simplified (OHI-S) and the WHO Oral Mucositis Scale. The research examines the impact of sociodemographic factors, oral hygiene practices, and treatment-related variables on oral health and overall quality of life, with a focus on radiotherapy and chemotherapy effects. While no interventions are applied, findings will support future strategies to improve post-treatment oral care for HNC survivors in Egypt. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Health-Related Quality of Life (OHRQoL) Score
The Oral Health-Related Quality of Life (OHRQoL) Score will be assessed using the EORTC QLQ-H\&N35 questionnaire, a validated tool for evaluating the impact of head and neck cancer (HNC) and its treatment on patients' oral health and overall quality of life. This questionnaire captures functional, social, and psychological aspects related to oral health, including pain, swallowing difficulties, dry mouth, speech problems, and social interactions.
Scores range from 0 to 100, with higher scores indicating worse OHRQoL and greater impairment in daily activities. This measure will help identify factors influencing post-treatment oral health outcomes and guide future supportive care strategies for HNC survivors in Egypt
Measured: single point "Baseline"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start15 Oct 2024
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CncerStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma ElSayed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901401
- Sponsor's protocol ID
- HAM00213
- Status last verified
- Mar 2025
- First submitted
- 23 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hassanein FEA, Abou-Bakr A, William H, Ahmed Y, Ibrahim SS. 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 Dec 27;26(1):181. doi: 10.1186/s12903-025-07488-9.
PubMed 41454361
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06901401
- Acronym / sponsor ID
- HAM00213
- Conditions
- Head and Neck Cncer
- Keywords
- Oral Health-Related Quality of Life (OHRQoL), Head and Neck Cancer (HNC), EORTC QLQ-H&N35
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 28 Mar 2025 (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.
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.
Detailed description
Head and neck cancer (HNC) is the seventh most common cancer globally, accounting for more than 660,000 new cases and 325,000 deaths annually. The number of HNC cases is expected to grow by 30% each year until 2030.[1] The rise has been observed in both developed and developing countries.[2] The survival for HNC has improved modestly over the past three decades with the introduction of different and multi-disciplinary treatment modalities.[3] There are several treatment options for HNC, including radiation therapy, surgery, and chemotherapy. These treatments can be used alone or in combination. Radiation therapy (RT) involves using high-energy beams to destroy cancer cells, while it is an important part of HNC treatment, it can also cause various toxicities, sometimes severe, toxicities.[4].
In most of the cases, head and neck tumors may destroy organs that play an important part in daily activities such as eating and speaking [5]. Additionally, the therapeutic approaches for the treatment of cancer usually result in collateral effects [6]. that impact in the quality of life. The assessment of the quality of life in patients with cancer became a valuable tool to investigate the progression of the disease and the effectiveness of the treatment [7].
The oral condition has an essential role in the individual's systemic health [8]. In specific, the quality of lifer elated to oral health (OHRQoL) may be defined as the lack of negative impact of the oral condition on social, psychological and functional activities [9]. In general, patients with tumors in the oral cavity figure amongst the worst indices for the quality of life when compared to patients with tumors in other regions [10]. Based on the exposed, the present study aimed to measure the impact of OHRQoL of patients with HNC and to evaluate the factors associated.
QoL assessment is an important tool for evaluating not only the impact of disease and its treatment on an individual level but also helpful in developing and revising the rehabilitative ser- vices and patient education material to further improve the clinical outcomes (survival) of patients [11]. Oral health related quality of life (OHRQoL), specifically focuses on self-report aspects pertaining to oral health, capturing the functional, social, and psychological dimensions affected by oral disease [12]. In the case of HNC, disruptions in key oral functions poses a higher risk of adversely affecting both OHRQoL and overall QoL[13].
Not much evidence is found in Egypt related to oral care measures for HNC patients, such as professional care by a dentist and dental hygienist (mechanical or manual removal of mucosal debris, oral hygiene counsel- ling, etc.) at least once a week until the completion of RT [14]. The patients are often unaware of the potential harm from the cancer treatment, only a proportion of HNC patients seek dental consultation for their complications, and most of them suffer greatly even after the completion of treatment due to disturbed oral functions.
To the best of our knowledge, this study represents the first comprehensive assessment of OHRQoL in HNC treated patients who had completed their cancer treatment within the past 12 months. Additionally, it aims to explore the associations between various oral clinical parameters, including oral hygiene status and oral mucositis, and several predictive factors such as sociodemographic characteristics and treatment-related variables in relation to OHRQoL. The findings of this study will highlights the importance of standardizing oral care and improving oral health support for HNC treated patients to reduce the impact of oral problems which can negatively impact their overall quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HNC Survivors' Oral Health and Quality of Life in Egypt | – | –This cohort includes head and neck cancer (HNC) survivors within the first year post-treatment at Ahmed Maher Teaching Hospital (AMTH) in Egypt. The study evaluates Oral Health-Related Quality of Life (OHRQoL) using the EORTC QLQ-H\&N35 questionnaire, along with clinical assessments like the Oral Hygiene Index-Simplified (OHI-S) and the WHO Oral Mucositis Scale. The research examines the impact of sociodemographic factors, oral hygiene practices, and treatment-related variables on oral health and overall quality of life, with a focus on radiotherapy and chemotherapy effects. While no interventions are applied, findings will support future strategies to improve post-treatment oral care for HNC survivors in Egypt. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include adult head and neck cancer (HNC) survivors who have completed surgery, radiotherapy, and/or chemotherapy within the past 12 months. Participants will be recruited from the oncology unit at Ahmed Maher Teaching Hospital (AMTH) in Egypt during their routine follow-up visits. The study population will consist of individuals aged 18 years and older, representing diverse sociodemographic backgrounds. Eligibility criteria include patients who can communicate and complete the EORTC QLQ-H\&N35 questionnaire, as well as those with at least one molar and one central incisor in both upper and lower dentition for oral hygiene assessment. Patients with cognitive impairments, severe debilitating conditions, or trismus (mouth opening <20mm) will be excluded. This study aims to evaluate the impact of cancer treatment on oral health-related quality of life (OHRQoL) and identify factors affecting post-treatment oral health outcomes in Egyptian HNC survivors.
Key inclusion criteria (6 listed)
- (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).
Key exclusion criteria (5 listed)
- 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).
- 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.
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
Oral Health-Related Quality of Life (OHRQoL) Score
Time frame: single point "Baseline"
The Oral Health-Related Quality of Life (OHRQoL) Score will be assessed using the EORTC QLQ-H\&N35 questionnaire, a validated tool for evaluating the impact of head and neck cancer (HNC) and its treatment on patients' oral health and overall quality of life. This questionnaire captures functional, social, and psychological aspects related to oral health, including pain, swallowing difficulties, dry mouth, speech problems, and social interactions. Scores range from 0 to 100, with higher scores indicating worse OHRQoL and greater impairment in daily activities. This measure will help identify factors influencing post-treatment oral health outcomes and guide future supportive care strategies for HNC survivors in Egypt
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Derived from this study: PubMed 41454361Hassanein FEA, Abou-Bakr A, William H, Ahmed Y, Ibrahim SS. 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 Dec 27;26(1):181. doi: 10.1186/s12903-025-07488-9.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Head and Neck Cncer, run by Ain Shams 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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 28 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Oral Health-Related Quality of Life (OHRQoL) Score (time frame: single point "Baseline"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06901401, which also lists 1 linked publication.
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 28 Mar 2025.