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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

Sponsored by Ain Shams University

About this trial

Last updated a year ago

Study ID

HAM00221

Status

Completed

Type

Observational

Placebo

No

Accepting

18+ Years
All Sexes

Trial Timing

Ended 2 years ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.