Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia (NCT07278557) | Clinical Trial Compass
RecruitingPhase 2
Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia
United States98 participantsStarted 2026-01-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The rate of xerostomia score based on the University of Michigan Xerostomia -6 months Questionnaire - 6 months