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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Ahmed Maher teaching hospital

    Cairo, 11565

Other trials in Egypt

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.

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 groups in NCT06730139
Study groupRoleWhat they receive
Head and Neck Cancer (HNC) SurvivorsTarget 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.

  1. 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.

  1. First posted12 Dec 2024
  2. Study start20 Dec 2023
  3. Primary completion20 Aug 2024
  4. Study completion30 Nov 2024

Resources

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)
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

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.

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