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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT07278557
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MRI sialography — DEVICE
    Prior to radiation therapy treatment planning, all participants will undergo magnetic resonance imaging (MRI) sialography in order to visualize patients' parotid ducts. This will enable these organs-at-risk to be spared during radiation treatment planning
  • Parotid Duct Sparing Radiation Therapy Planning — OTHER
    Radiation therapy will be administered based on treatment planning that aims to minimize the dose to the parotid ducts.
  • Parotid Sparing Radiation Therapy Planning — OTHER
    Radiation therapy will be administered based on treatment planning that uses the entire parotid gland volume as the organ-at-risk, in accordance with standard clinical practice. The parotid ducts will not be considered separately.

Study Details

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.

Key Dates

Start date
Jan 28, 2026
Status verified
Jan 2026
Primary completion
Feb 28, 2030
Completion
Feb 28, 2030

Study Design

Enrollment
98 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Experimental Arm
    Participants randomized to this arm will have their organs-at-risk include the expanded parotid ducts. Treatment planning will aim to explicitly minimize the dose to these structures. If achieving this dose is not possible, it will be documented as a study deviation, but treatment will proceed.
  • Active Comparator: Standard Arm
    Participants in this arm will undergo treatment planning using the overall parotid gland volume as the organ-at-risk, following the standard clinical practice. Entire parotid gland will be considered, not the parotid ducts.

Primary Outcome Measure

The rate of xerostomia score based on the University of Michigan Xerostomia -6 months Questionnaire - 6 months [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel Hill, Department of Radiation OncologyChapel HillNorth Carolina27599
Tuvara V. King
[email protected]
919-966-3036
Melissa Knutsen
[email protected]
9199663036
David V. Fried, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
University of North Carolina at Chapel Hill, Department of Radiation Oncology· Chapel Hill, NC

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