Head and Neck CancerNCT06730139
Oral Health Related Quality of Life in Head and Neck Cancer Survivors Within the First Year Following Treatment
An observational study of Head and Neck Cancer, run by Ain Shams University at 1 site in Egypt.
Trial summary
Oral Health-Related Quality of Life in Head and Neck Cancer Patients Problem Statement: Head and Neck Cancer (HNC) is a significant global health issue, and its incidence is rising. While treatment options have improved, they often lead to severe oral complications, impacting patients' quality of life. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Cancer
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2023to 30 Nov 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will consist of HNC survivors who meet the following criteria: Age: 18 years and older Treatment Completion: Within the past year Dental Status: Presence of at least one molar and one central incisor in the upper and lower jaw Cognitive Function: No cognitive disabilities or debilitating conditions Mouth Opening: Minimum of 20 mm Participants will be recruited from the oncology unit at Ahmed Maher Teaching Hospital (AMTH) during their routine follow-up visits. Eligible patients will be informed about the study and provided with a written informed consent form.
Who may be able to join
- Age 18 years and above
- Diagnosed with HNC
- Within the first year post-cancer treatment
- Scheduled for a routine follow-up visit at AMTH
- Presence of at least one molar and one central incisor in each jaw
- Able to provide informed consent
Who cannot join
- Inability to provide informed consent
- Debilitative conditions or cognitive disabilities
- Trismus (mouth opening < 20 mm)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Health Related Quality of Life in Head and Neck Cancer Survivors Within the First Year Following Treatment: a Cross Sectional Study in Egypt
Oral Health-Related Quality of Life in Head and Neck Cancer Patients
Problem Statement:
Read more
Head and Neck Cancer (HNC) is a significant global health issue, and its incidence is rising. While treatment options have improved, they often lead to severe oral complications, impacting patients' quality of life.
Research Gap:
Limited research exists on oral health-related quality of life (OHRQoL) among HNC patients in Egypt, particularly focusing on the impact of oral clinical parameters and treatment-related factors.
Research Objective:
To assess the OHRQoL of HNC patients who have completed treatment within the past 12 months and to identify factors associated with impaired OHRQoL.
Methodology:
This study will employ a comprehensive approach to evaluate OHRQoL, considering:
Oral Clinical Parameters: Oral hygiene status, oral mucositis, and other oral health indicators.
Sociodemographic Factors: Age, gender, education, occupation, and socioeconomic status.
Treatment-Related Variables: Type of treatment (surgery, radiation therapy, chemotherapy), treatment duration, and dose intensity.
Expected Outcomes:
The findings of this study will:
Quantify the impact of HNC treatment on OHRQoL. Identify key factors associated with impaired OHRQoL. Highlight the importance of standardized oral care for HNC patients. Provide evidence-based recommendations for improving oral health support and enhancing the overall quality of life for HNC survivors.
By addressing the oral health needs of HNC patients, this research aims to improve their quality of life and contribute to better long-term outcomes.
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 Cancer
- Keywords
- Head and Neck Cancer (HNC), Oral Health-Related Quality of Life (OHRQoL), Radiation Therapy (RT), Oral Complications, Quality of Life
- 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 |
|---|---|---|
| Head and Neck Cancer (HNC) Survivors | Target Population: Age: 18 years and older Diagnosis: Head and Neck Cancer (HNC) Treatment Status: Within the first year post-treatment completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
European Organization for Treatment of Cancer Quality of Life Questionnaire for Head and Neck Cancer (EORTC QLQ-H&N-35).
EORTC QLQ-H\&N-35 Minimum Score: 0 Maximum Score: 100 Higher Scores: Indicate worse outcomes and more severe symptoms.
Domains Evaluated:
Functional Domains:
Pain and soreness in the mouth and throat
Swallowing difficulties Taste and smell alterations Social eating and enjoyment of meals Social contact Sexuality
Symptom Scale:
Teeth problems Mouth opening difficulties Dry mouth Sticky saliva Coughing Feeling ill Pain killer use
Nutritional supplement or feeding tube use
Weight loss
Weight gain
Measured: Assessed once during the study (day 1 of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start20 Dec 2023
- Primary completion20 Aug 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
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
- NCT06730139
- Sponsor's protocol ID
- MAM00213
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Related Quality of Life in Head and Neck Cancer Survivors Within the First Year Following Treatment: a Cross Sectional Study in Egypt
- ClinicalTrials.gov ID
- NCT06730139
- Acronym / sponsor ID
- MAM00213
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer (HNC), Oral Health-Related Quality of Life (OHRQoL), Radiation Therapy (RT), Oral Complications, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 12 Dec 2024 (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.
Oral Health-Related Quality of Life in Head and Neck Cancer Patients
Problem Statement:
Head and Neck Cancer (HNC) is a significant global health issue, and its incidence is rising. While treatment options have improved, they often lead to severe oral complications, impacting patients' quality of life.
Research Gap:
Limited research exists on oral health-related quality of life (OHRQoL) among HNC patients in Egypt, particularly focusing on the impact of oral clinical parameters and treatment-related factors.
Research Objective:
To assess the OHRQoL of HNC patients who have completed treatment within the past 12 months and to identify factors associated with impaired OHRQoL.
Methodology:
This study will employ a comprehensive approach to evaluate OHRQoL, considering:
Oral Clinical Parameters: Oral hygiene status, oral mucositis, and other oral health indicators.
Sociodemographic Factors: Age, gender, education, occupation, and socioeconomic status.
Treatment-Related Variables: Type of treatment (surgery, radiation therapy, chemotherapy), treatment duration, and dose intensity.
Expected Outcomes:
The findings of this study will:
Quantify the impact of HNC treatment on OHRQoL. Identify key factors associated with impaired OHRQoL. Highlight the importance of standardized oral care for HNC patients. Provide evidence-based recommendations for improving oral health support and enhancing the overall quality of life for HNC survivors.
By addressing the oral health needs of HNC patients, this research aims to improve their quality of life and contribute to better long-term outcomes.
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
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head and Neck Cancer (HNC) Survivors | – | –Target Population: Age: 18 years and older Diagnosis: Head and Neck Cancer (HNC) Treatment Status: Within the first year post-treatment completion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of HNC survivors who meet the following criteria: Age: 18 years and older Treatment Completion: Within the past year Dental Status: Presence of at least one molar and one central incisor in the upper and lower jaw Cognitive Function: No cognitive disabilities or debilitating conditions Mouth Opening: Minimum of 20 mm Participants will be recruited from the oncology unit at Ahmed Maher Teaching Hospital (AMTH) during their routine follow-up visits. Eligible patients will be informed about the study and provided with a written informed consent form.
Key inclusion criteria (6 listed)
- Age 18 years and above
- Diagnosed with HNC
- Within the first year post-cancer treatment
- Scheduled for a routine follow-up visit at AMTH
- Presence of at least one molar and one central incisor in each jaw
Key exclusion criteria (3 listed)
- Inability to provide informed consent
- Debilitative conditions or cognitive disabilities
- Trismus (mouth opening < 20 mm)
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
European Organization for Treatment of Cancer Quality of Life Questionnaire for Head and Neck Cancer (EORTC QLQ-H&N-35).
Time frame: Assessed once during the study (day 1 of the study)
EORTC QLQ-H\&N-35 Minimum Score: 0 Maximum Score: 100 Higher Scores: Indicate worse outcomes and more severe symptoms. Domains Evaluated: Functional Domains: Pain and soreness in the mouth and throat Swallowing difficulties Taste and smell alterations Social eating and enjoyment of meals Social contact Sexuality Symptom Scale: Teeth problems Mouth opening difficulties Dry mouth Sticky saliva Coughing Feeling ill Pain killer use Nutritional supplement or feeding tube use Weight loss Weight gain
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 12 Dec 2024.
- Individual participant dataSharing planned: No
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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 Cancer, 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 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 12 Dec 2024. 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?
European Organization for Treatment of Cancer Quality of Life Questionnaire for Head and Neck Cancer (EORTC QLQ-H&N-35). (time frame: Assessed once during the study (day 1 of the study)). 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 12 Dec 2024.