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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

NCT06851572 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 260

Last updated 2025-02-28

No results posted yet for this study

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. 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.

Conditions

  • Radiotherapy Side Effect
  • Xerostomia Due to Radiotherapy
  • Xerostomia Due to Radiotherapy (Disorder)

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-20
Primary Completion
2024-03-01
Completion
2024-07-20

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06851572 on ClinicalTrials.gov