Parotid Duct Sparing Radiation for Head and Neck Cancers

Overseen By Melissa Knutsen

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: UNC Lineberger Comprehensive Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

David Fried, PhD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with oropharyngeal cancer who are about to receive definitive radiotherapy. It's designed to see if sparing the parotid ducts during treatment can reduce dry mouth symptoms after therapy.

Inclusion Criteria

Women of reproductive potential must use highly effective contraception

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

Exclusion Criteria

Current pregnancy or lactation

Patients with an allergy to lemon juice

My scans show issues with my salivary glands.

What Are the Treatments Tested in This Trial?

Interventions

• MRI sialography
• Parotid Duct Sparing Radiation Therapy Planning
• Parotid Sparing Radiation Therapy Planning

Trial Overview The study compares two radiation planning techniques: MRI-guided parotid ductal sparing versus standard mean parotid gland sparing. The goal is to determine which method better prevents dry mouth in patients post-treatment.

How Is the Trial Designed?

Group I: Experimental Arm Experimental Treatment 2 Interventions

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.

Group II: Standard Arm Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+