Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07278557

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

Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-02-03

98

Participants Needed

1

Research Sites

209 weeks

Total Duration

On this page

Sponsors

U

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

N

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide written informed consent and HIPAA authorization
  • Able to comply with study procedures
  • Male or female aged 18 years or older
  • Eastern Cooperative Oncology Group performance status 0-2
  • Women of reproductive potential must use highly effective contraception
  • Diagnosed with T0-4, N0-3, M0 oropharyngeal cancer planned for definitive radiotherapy with or without chemotherapy
  • No contraindications for MRI
Not Eligible

You will not qualify if you...

  • Diagnosis of Sjogren's disease or baseline xerostomia
  • Lesions involving the salivary glands on diagnostic imaging
  • Allergy to lemon juice
  • Prior lifetime radiation therapy to the head and neck
  • Current pregnancy or lactation

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of North Carolina at Chapel Hill, Department of Radiation Oncology

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

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Research Team

T

Tuvara King

CONTACT

M

Melissa Knutsen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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