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 | Completed DMC

• 1 other identifier: HAM00221
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

dry mouth, xerostomia, hyposalivation, head and neck, cancer, radiotherapy.

Outcome Measures

Primary Outcomes (1)

• 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.

  single point "Baseline"

Secondary Outcomes (2)

• unstimulated salivary flow rate

  single point "Baseline"

• Quality of Life (QoL)

  single point "Baseline"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ahmed Maher Hospital

Cairo, Cairo Governorate, 11277, Egypt

Location

MeSH Terms

Conditions

Radiation Injuries; Xerostomia; Neoplasms

Condition Hierarchy (Ancestors)

Wounds and Injuries; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 28, 2025
• Study Start: March 20, 2023
• Primary Completion: March 1, 2024
• Study Completion: July 20, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

EG (1)