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Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 4 of 4 entries
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2026 to Jan 28, 2026
    • Site details revised
    v3
  3. Minor Start date: Dec 2025 to Jan 2026v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Radiation-induced xerostomia (dry mouth) is one of the most common and severe side effects for patients receiving radiation therapy for head and neck cancer. New approaches are needed to reduce this side effect and improve patients' quality of life after treatment. This is a Phase II, single-center, double-masked, parallel-arm, randomized controlled trial. It compares MRI-guided parotid ductal sparing to the standard approach of mean parotid gland sparing, focusing on patient-reported dry mouth outcomes in individuals receiving definitive radiotherapy for oropharyngeal cancer.
Trial Details
NCT Number NCT07278557
Lead Sponsor UNC Lineberger Comprehensive Cancer Center
Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
Conditions
(from sponsor)
Head and Neck Cancer
Related terms Head and Neck Neoplasms
Enrollment 98 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov