Using MRI to spare parotid salivary ducts to reduce dry mouth
Assessment of Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia Following Radiotherapy for Oropharynx Cancer
This study tests whether using MRI to identify and protect parotid salivary ducts during radiation can reduce long-term dry mouth for people receiving definitive radiotherapy for oropharyngeal cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT07278557 on ClinicalTrials.gov |
What this trial studies
This Phase II, single-center, double-masked, parallel-arm randomized trial compares MRI-guided parotid ductal sparing radiation planning to standard mean parotid gland sparing in patients getting definitive radiotherapy for oropharyngeal cancer. MRI sialography is used during treatment planning to map major parotid ducts and guide dose constraints aimed at preserving ductal regions thought to harbor regenerative cells. Participants are randomized to either duct-sparing planning or standard gland-based sparing and receive radiotherapy with or without concurrent chemotherapy per standard clinical indications. The primary outcomes focus on patient-reported xerostomia and related quality-of-life measures after treatment.
Who should consider this trial
Good fit: Adults (≥18 years) with T0-4, N0-3, M0 oropharyngeal cancer planned for definitive radiotherapy ± chemotherapy, ECOG 0–2, able to undergo MRI and comply with study procedures are ideal candidates.
Not a fit: Patients with non-oropharyngeal or metastatic disease, prior head and neck radiation, contraindications to MRI, or those whose anatomy prevents duct sparing or who already have severe salivary gland dysfunction are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could lower radiation-related dry mouth symptoms and improve long-term oral comfort and quality of life for treated patients.
How similar studies have performed: Prior work on sparing parotid subregions and reducing overall parotid dose has shown some reduction in xerostomia, but MRI sialography–guided ductal sparing is a newer, less-tested approach with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: To participate in this study a subject must meet all of the eligibility criteria outlined below. Eligibility must be maintained for the subject to be considered eligible for ongoing trial participation. * Provide written informed consent to participate in the study and HIPAA authorization for release of personal health information. * Able to comply with study procedures based on the judgment of the clinical investigator. * Male or female, aged ≥ 18 years at the time of consent. * Eastern Cooperative Oncology Group performance status 0-2 at the time of consent. * Women of reproductive potential must use highly effective contraception. * T0-4, N0-3, M0 stage cancer of the oropharynx (American Joint Committee on Cancer Staging System 8th edition) planned for definitive radiotherapy +/- chemotherapy. * No contraindications for magnetic resonance imaging (MRI). Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation In this study: * Patients with Sjogren's disease or baseline xerostomia. * Patients with lesions involving the salivary glands on diagnostic imaging * Patients with an allergy to lemon juice * Prior lifetime history of radiation therapy to the head and neck * Current pregnancy or lactation.
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill, Department of Radiation Oncology — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: David Fried, PhD — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Tuvara King
- Email: tjking@med.unc.edu
- Phone: (984) 974-0000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.