Using MRI to spare parotid salivary ducts to reduce dry mouth

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.