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

NCT07278557 | Recruiting Phase 2 DMC FDA Device

• 2 other identifiers: LCCC2444UG3DE033389
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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

Head and Neck Cancer

Keywords

Radiation-induced xerostomia; parotid gland dose; radiation dose; parotd sparing; MRI sialography

Outcome Measures

Primary Outcomes (1)

• The rate of xerostomia score based on the University of Michigan Xerostomia -6 months Questionnaire - 6 months

  The rate of xerostomia score based on the University of Michigan Xerostomia Questionnaire (UMXQ) will be determined. UMXQ is an eight-item patient-reported instrument designed to assess the severity of xerostomia (dry mouth), gauging symptoms both during and outside of eating or chewing. The score ranges from 0 to 100, with higher scores indicating worse xerostomia. Participants treated with parotid ductal sparing radiotherapy will be compared.

  6 months

Secondary Outcomes (4)

• Salivary flow unstimulated

  at 6 and 12 months

• Salivary flow stimulated

  at 6 and 12 months

• The rate of xerostomia score based on the University of Michigan Xerostomia Questionnaire- 12 months

  12 months

• The rate of xerostomia score based on the MD Anderson Symptom Inventory Head and Neck (MDASI - HN)- 12 months

  12 months

Study Arms (2)

Experimental Arm

EXPERIMENTAL

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.

Device: MRI sialography; Other: Parotid Duct Sparing Radiation Therapy Planning

Standard Arm

ACTIVE COMPARATOR

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.

Device: MRI sialography; Other: Parotid Sparing Radiation Therapy Planning

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

Experimental Arm; Standard Arm

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.

Standard Arm

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.

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

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

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• David Fried, PhD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuvara King

CONTACT

(984) 974-0000; tjking@med.unc.edu

Melissa Knutsen

CONTACT

(984) 974-0000; Melissa_Knutsen@med.unc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: This study is double-masked, ensuring that both treating physicians and study participants are masked to treatment assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 12, 2025
• Study Start: January 28, 2026
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)