NCT06276946

Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia

Randomized Assessment of Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia Following Radiotherapy for Oropharynx Cancer

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Radiation-induced xerostomia (dry mouth) is one of the most common and severe toxicities experienced by patients undergoing radiation treatment for head and neck cancer. Radiation-induced dry mouth is a frequently experienced symptom and persists after treatment, potentially indefinitely. Current practice does not specifically attempt to spare the parotid ducts, where stem/progenitor cells are believed to preferentially reside, and considers the entire salivary gland to have equal function. New radiation therapy planning and conducting strategies are needed to reduce this toxicity and maximize patient quality of life post-treatment. This randomized Phase II study explores the contribution of magnetic resonance imaging (MRI) guided salivary gland duct definition to decrease patient-reported xerostomia in patients with oropharynx cancer receiving radiation therapy. The severity of xerostomia will be measured by patient-reported (PRO) symptoms, saliva secretion, saliva pH, and buffering.

Conditions

• Oropharynx Cancer
• Head and Neck Cancer
• Xerostomia

Interventions

Type	Name	Description
RADIATION	standard radiotherapy	radiotherapy planning goal is to restrict the mean parotid dose is equal to or less than 14Gy.
RADIATION	experimental radiotherapy	radiotherapy planning goal is to restrict the parotid duct dose is equal to or less than 14Gy

Timeline

• Start date: 2025-08-08
• Primary completion: 2028-07-01
• Completion: 2029-01-01
• First posted: 2024-02-26
• Last updated: 2025-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study