Recruiting
Phase 2

MRI-guided Sparing

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT07278557

Conditions

Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MRI sialography

Parotid Duct Sparing Radiation Therapy Planning

Parotid Sparing Radiation Therapy Planning

Study Details

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

Study ID

NCT07278557

Start date

Jan 28, 2026

Status verified date

Jan, 2026

Completion date

Feb, 2030

Anticipated

Primary completion date

Feb, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

98 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Experimental Arm

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.

active comparator: Standard Arm

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.

Interventions

MRI sialography

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

Parotid Duct Sparing Radiation Therapy Planning

Radiation therapy will be administered based on treatment planning that aims to minimize the dose to the parotid ducts.

Parotid Sparing Radiation Therapy Planning

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.

Primary outcome measure

  • The rate of xerostomia score based on the University of Michigan Xerostomia -6 months Questionnaire - 6 months [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Tuvara King

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

Melissa Knutsen

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

Locations

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

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Tuvara V. King

919-966-3036tjking@med.unc.edu

Melissa Knutsen

9199663036Melissa_Knutsen@med.unc.edu

Principal Investigator:

David V. Fried, PhD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Feb 3, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-02-03.