Radiotherapy Side EffectNCT06851572
Prevalence of Late Xerostomia and Hyposalivation with Associated Risk Factors in Survivors of Head and Neck Cancer After Radiotherapy: a Multi-centric Cross-sectional Study
An observational study of Radiotherapy Side Effect and Xerostomia Due to Radiotherapy, run by Ain Shams University at 1 site in Egypt.
Trial summary
The study titled "Prevalence of Late Xerostomia and Hyposalivation with Associated Risk Factors in Survivors of Head and Neck Cancer After Radiotherapy" is a multi-centric cross-sectional study conducted in Egypt. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiotherapy Side Effect, Xerostomia Due to Radiotherapy, Xerostomia Due to Radiotherapy (Disorder)
- How many people
- 260 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2023to 20 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study focuses on long-term survivors of head and neck cancer (HNC) who have undergone curative radiotherapy with or without chemotherapy. The population includes both male and female patients who have completed their treatment at least one year prior to participation. Patients will be recruited from multiple medical centers, ensuring a diverse and representative sample of HNC survivors. The study aims to assess the prevalence of late-onset xerostomia and hyposalivation, along with associated risk factors such as treatment type, tumor characteristics, smoking status, and sociodemographic variables. The study specifically targets individuals aged 18 years or older, with no recurrent or secondary primary malignancies, and who are willing to participate in subjective and objective assessments of salivary gland dysfunction.
Who may be able to join
- Head and Neck Cancer (HNC) Survivors
- Must have completed curative radiotherapy for HNC at least 1 year prior (with or without chemotherapy).
- Aged 18 years or older. Willing to provide informed consent and undergo dry mouth assessment.
Who cannot join
- Recurrent or Secondary Malignancies
- Patients with recurrent HNC or a new secondary primary cancer before survey administration.
- ❌ Severe Comorbid Conditions
- Any systemic disease or medical condition that significantly impacts salivary function (e.g., Sjögren's syndrome, uncontrolled diabetes, autoimmune diseases).
- ❌ Recent Radiotherapy or Ongoing Cancer Treatment
- Patients who underwent radiation within the past year. Those receiving active cancer treatment during the study period.
- ❌ Non-Consent or Cognitive Impairment
- Patients who are unwilling to participate or unable to complete questionnaires due to cognitive dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
The study titled "Prevalence of Late Xerostomia and Hyposalivation with Associated Risk Factors in Survivors of Head and Neck Cancer After Radiotherapy" is a multi-centric cross-sectional study conducted in Egypt. It aims to assess the prevalence of late-onset xerostomia (dry mouth) and hyposalivation in survivors of head and neck cancer (HNC) who have undergone radiotherapy. Given the widespread use of radiotherapy as a treatment for HNC, its long-term side effects-especially on salivary gland function-are a major concern for patient quality of life.
The study includes 260 participants who have completed curative radiotherapy at least one year prior, with or without chemotherapy. Patients were selected from multiple centers, and eligibility criteria required them to be at least 18 years old. Those with recurrent or secondary malignancies were excluded. The researchers hypothesized that high doses of radiation administered to the salivary glands would lead to a high prevalence of xerostomia, and that concomitant chemotherapy might further exacerbate this condition.
Read more
To evaluate xerostomia, both subjective and objective assessments were conducted. The Summated Xerostomia Inventory (SXI), a five-item questionnaire, was used to measure self-reported symptoms of dry mouth. Objective assessments included salivary flow rate measurement, oral dryness indicators, and glandular response to stimulation. Additionally, the MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) was used to assess the impact of xerostomia on daily functioning and quality of life.
The study also examined various risk factors associated with xerostomia, including tumor site, treatment type (radiotherapy alone or with chemotherapy), demographic factors (age, gender, education level), and lifestyle habits (such as smoking status). Smoking history was classified into never smokers, former smokers (quit >6 months before diagnosis), and current smokers (either quit post-diagnosis or continued smoking).
This research is significant as it is one of the first large-scale studies in Egypt to evaluate long-term salivary dysfunction in head and neck cancer survivors. By identifying prevalence rates and contributing factors, the study provides valuable insights for improving patient care and developing better management strategies for individuals suffering from post-radiotherapy xerostomia.
Read the detailed description
Cancer of the oral cavity, pharynx, and larynx corresponds to approximately 4.6% of all cases of cancer worldwide.[1] In 2018, 834,860 new cases of cancer in these anatomic sites were diagnosed.[1] When anatomic sub-sites are analyzed, the incidence of cancer of the mouth and oropharynx is higher, followed by cancer of the larynx and hypopharynx.[2] Due to demographic changes, the number of cases of lip, mouth, and pharyngeal cancer is expected to increase by 62%, reaching 856,000 cases annually by 2035.[3] Radiotherapy (RT) is widely employed in the treatment of head and neck cancer used as primary therapy, adjunct therapy to surgery, with concomitant chemotherapy (CT) or as palliative treatment. High doses of RT can negatively affect the soft and hard tissues of the oral cavity.[4] Patients with head and neck cancer are generally irradiated with high doses (50 to 70 Gy),[5] which side-effects include xerostomia, trismus, and dysphagia; in hard tissues, the effects may be osteoradionecrosis and radiation caries all of which have a late-onset.[4] One of the main problems resulting from radiotherapy in the head and neck region is the damage to glandular tissues, reducing the salivary flow.[6] Xerostomia occurs due to cell death and fibrosis of the glandular tissue caused by radiotherapy, leading to a sensation of dry mouth (xerostomia).[7] Some studies suggest a significant increase in late onset xerostomia in patients treated with concomitant chemotherapy and radiotherapy,[8] whereas other authors state that there is no strong evidence of the additive effect of chemotherapy concomitant to radiotherapy on hypofunction of the salivary glands.[9] In a systematic review, Jensen, et al.[9] (2010) found divergences in the literature regarding hyposalivation and xerostomia. According to some authors, the term xerostomia is often used as a synonym of hyposalivation, when it should only be used to indicate the perception of dry mouth reported by the patient.[3] Due to this common late effect in patients irradiated in head and neck and the influence on their quality of life, studies bringing new information to the field are necessary. Therefore, this study evaluates the prevalence and factors associated with late xerostomia based on the stimulated salivary flow rate in patients treated with Intensity-modulated radiation therapy (IMRT) with or without concomitant chemotherapy for the treatment of cancer of the oral cavity, oropharynx, hypopharynx, or larynx. We hypothesize that a high prevalence would be found caused by high doses of radiation in the salivary glands and also influenced by the type of therapy used in this region in Egypt.
- Conditions
- Radiotherapy Side Effect, Xerostomia Due to Radiotherapy, Xerostomia Due to Radiotherapy (Disorder)
- Keywords
- dry mouth, xerostomia, hyposalivation, head and neck, cancer, radiotherapy.
- Medical subject headings
- Radiation Injuries, Xerostomia, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Summated Xerostomia Inventory (SXI)
the Summated Xerostomia Inventory (SXI), which consists of five subjective statements related to dry mouth symptoms. Each statement is scored from 1 (never) to 3 (often), with a maximum score of 15, indicating severe xerostomia.
Measured: single point "Baseline"
Secondary outcomes (2)
unstimulated salivary flow rate
Measured using unstimulated salivary flow rate collected over 5 minutes and expressed in mL/min. Patients will be classified as having normal, reduced, or absent salivary flow.
Measured: single point "Baseline"
Quality of Life (QoL)
Assessed using the MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN), a 28-item questionnaire measuring symptom severity and daily life interference on a 0-10 scale.
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 Feb 2025
- Study start20 Mar 2023
- Primary completion1 Mar 2024
- Study completion20 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiotherapy Side EffectStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 260 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
- NCT06851572
- Sponsor's protocol ID
- HAM00221
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Late Xerostomia and Hyposalivation with Associated Risk Factors in Survivors of Head and Neck Cancer After Radiotherapy: a Multi-centric Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06851572
- Acronym / sponsor ID
- HAM00221
- Conditions
- Radiotherapy Side Effect, Xerostomia Due to Radiotherapy, Xerostomia Due to Radiotherapy (Disorder)
- Keywords
- dry mouth, xerostomia, hyposalivation, head and neck, cancer, radiotherapy.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 28 Feb 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.
The study titled "Prevalence of Late Xerostomia and Hyposalivation with Associated Risk Factors in Survivors of Head and Neck Cancer After Radiotherapy" is a multi-centric cross-sectional study conducted in Egypt. It aims to assess the prevalence of late-onset xerostomia (dry mouth) and hyposalivation in survivors of head and neck cancer (HNC) who have undergone radiotherapy. Given the widespread use of radiotherapy as a treatment for HNC, its long-term side effects-especially on salivary gland function-are a major concern for patient quality of life.
The study includes 260 participants who have completed curative radiotherapy at least one year prior, with or without chemotherapy. Patients were selected from multiple centers, and eligibility criteria required them to be at least 18 years old. Those with recurrent or secondary malignancies were excluded. The researchers hypothesized that high doses of radiation administered to the salivary glands would lead to a high prevalence of xerostomia, and that concomitant chemotherapy might further exacerbate this condition.
To evaluate xerostomia, both subjective and objective assessments were conducted. The Summated Xerostomia Inventory (SXI), a five-item questionnaire, was used to measure self-reported symptoms of dry mouth. Objective assessments included salivary flow rate measurement, oral dryness indicators, and glandular response to stimulation. Additionally, the MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) was used to assess the impact of xerostomia on daily functioning and quality of life.
The study also examined various risk factors associated with xerostomia, including tumor site, treatment type (radiotherapy alone or with chemotherapy), demographic factors (age, gender, education level), and lifestyle habits (such as smoking status). Smoking history was classified into never smokers, former smokers (quit >6 months before diagnosis), and current smokers (either quit post-diagnosis or continued smoking).
This research is significant as it is one of the first large-scale studies in Egypt to evaluate long-term salivary dysfunction in head and neck cancer survivors. By identifying prevalence rates and contributing factors, the study provides valuable insights for improving patient care and developing better management strategies for individuals suffering from post-radiotherapy xerostomia.
Detailed description
Cancer of the oral cavity, pharynx, and larynx corresponds to approximately 4.6% of all cases of cancer worldwide.[1] In 2018, 834,860 new cases of cancer in these anatomic sites were diagnosed.[1] When anatomic sub-sites are analyzed, the incidence of cancer of the mouth and oropharynx is higher, followed by cancer of the larynx and hypopharynx.[2] Due to demographic changes, the number of cases of lip, mouth, and pharyngeal cancer is expected to increase by 62%, reaching 856,000 cases annually by 2035.[3] Radiotherapy (RT) is widely employed in the treatment of head and neck cancer used as primary therapy, adjunct therapy to surgery, with concomitant chemotherapy (CT) or as palliative treatment. High doses of RT can negatively affect the soft and hard tissues of the oral cavity.[4] Patients with head and neck cancer are generally irradiated with high doses (50 to 70 Gy),[5] which side-effects include xerostomia, trismus, and dysphagia; in hard tissues, the effects may be osteoradionecrosis and radiation caries all of which have a late-onset.[4] One of the main problems resulting from radiotherapy in the head and neck region is the damage to glandular tissues, reducing the salivary flow.[6] Xerostomia occurs due to cell death and fibrosis of the glandular tissue caused by radiotherapy, leading to a sensation of dry mouth (xerostomia).[7] Some studies suggest a significant increase in late onset xerostomia in patients treated with concomitant chemotherapy and radiotherapy,[8] whereas other authors state that there is no strong evidence of the additive effect of chemotherapy concomitant to radiotherapy on hypofunction of the salivary glands.[9] In a systematic review, Jensen, et al.[9] (2010) found divergences in the literature regarding hyposalivation and xerostomia. According to some authors, the term xerostomia is often used as a synonym of hyposalivation, when it should only be used to indicate the perception of dry mouth reported by the patient.[3] Due to this common late effect in patients irradiated in head and neck and the influence on their quality of life, studies bringing new information to the field are necessary. Therefore, this study evaluates the prevalence and factors associated with late xerostomia based on the stimulated salivary flow rate in patients treated with Intensity-modulated radiation therapy (IMRT) with or without concomitant chemotherapy for the treatment of cancer of the oral cavity, oropharynx, hypopharynx, or larynx. We hypothesize that a high prevalence would be found caused by high doses of radiation in the salivary glands and also influenced by the type of therapy used in this region in Egypt.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study focuses on long-term survivors of head and neck cancer (HNC) who have undergone curative radiotherapy with or without chemotherapy. The population includes both male and female patients who have completed their treatment at least one year prior to participation. Patients will be recruited from multiple medical centers, ensuring a diverse and representative sample of HNC survivors. The study aims to assess the prevalence of late-onset xerostomia and hyposalivation, along with associated risk factors such as treatment type, tumor characteristics, smoking status, and sociodemographic variables. The study specifically targets individuals aged 18 years or older, with no recurrent or secondary primary malignancies, and who are willing to participate in subjective and objective assessments of salivary gland dysfunction.
Key inclusion criteria (3 listed)
- Head and Neck Cancer (HNC) Survivors
- Must have completed curative radiotherapy for HNC at least 1 year prior (with or without chemotherapy).
- Aged 18 years or older. Willing to provide informed consent and undergo dry mouth assessment.
Key exclusion criteria (8 listed)
- Recurrent or Secondary Malignancies
- Patients with recurrent HNC or a new secondary primary cancer before survey administration.
- ❌ Severe Comorbid Conditions
- Any systemic disease or medical condition that significantly impacts salivary function (e.g., Sjögren's syndrome, uncontrolled diabetes, autoimmune diseases).
- ❌ Recent Radiotherapy or Ongoing Cancer Treatment
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
Summated Xerostomia Inventory (SXI)
Time frame: single point "Baseline"
the Summated Xerostomia Inventory (SXI), which consists of five subjective statements related to dry mouth symptoms. Each statement is scored from 1 (never) to 3 (often), with a maximum score of 15, indicating severe xerostomia.
2 secondary outcomes
unstimulated salivary flow rate
Time frame: single point "Baseline"
Quality of Life (QoL)
Time frame: single point "Baseline"
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 28 Feb 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Radiotherapy Side Effect
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
RecruitingObservational study
3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
Not yet recruitingPhase 2
The Impact of Using Nicorandil for the Prevention of Doxorubicin-Induced Cardiotoxicity
Doxorubicin Induced Cardiotoxicity, Doxorubicin Induced Cardiomyopathy
Not yet recruitingObservational study
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
Heart Failure, Coronary Artery Disease
Not yet recruiting
Monitoring for CardioToxicity Using WeArable deVices While Undergoing cancEr Treatments (MCT-WAVE)
Cardiotoxicity, Cancer
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 Radiotherapy Side Effect and Xerostomia Due to Radiotherapy, 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 3 inclusion and 8 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 28 Feb 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?
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?
Summated Xerostomia Inventory (SXI) (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?
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 Feb 2025.