Head and Neck CancerPhase 2NCT07278557
Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia
A Phase 2 study testing MRI sialography, Parotid Duct Sparing Radiation Therapy Planning and Parotid Sparing Radiation Therapy Planning in people with Head and Neck Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- MRI sialography, Parotid Duct Sparing Radiation Therapy Planning and Parotid Sparing Radiation Therapy Planning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2026to Feb 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, 27599
Tuvara V. King, 919-966-3036, tjking@med.unc.edu
Melissa Knutsen, 9199663036, Melissa_Knutsen@med.unc.edu
About this study
Official title: Assessment of Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia Following Radiotherapy for Oropharynx Cancer
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.
Read the detailed description
Radiation-induced dry mouth (xerostomia) is the most commonly reported long-term side effect in patients receiving radiation therapy (RT) for head and neck cancer. It occurs when saliva production decreases and the saliva becomes thicker. Patients with xerostomia often have trouble chewing, swallowing, and speaking, and are more likely to develop tooth decay. These problems can significantly lower a patient's quality of life-and the impact tends to get worse over time.
The most common way to reduce radiation-related dry mouth is by limiting the average radiation dose to the parotid glands (which produce saliva). However, this is often not possible because of the patient's anatomy, and many patients still report moderate to severe symptoms long after treatment.
To reduce side effects, some studies have tested giving a lower radiation dose (60Gy instead of the usual 70Gy) in patients with low-risk, HPV-associated tumors. While this has helped improve overall symptoms, xerostomia still remains the most severe and persistent problem reported by patients.
New strategies are needed to better protect patients from radiation-related dry mouth and help maintain their quality of life after treatment. Recent research shows that the parotid gland does not respond evenly to radiation; certain areas, especially large salivary ducts where stem/progenitor cells live, may be key for recovery after damage. If these ducts can be located during treatment planning, the radiation dose to them could be reduced.
A pilot study showed that using MRI sialography to identify the parotid ducts and plan radiation therapy around them is both possible and promising. Patients who received this type of duct-sparing RT had fewer moderate-to-severe dry mouth symptoms compared to patients treated with standard RT (46% vs. 71% at 6 months, and 36% vs. 50% at 12 months post-treatment).
A larger, randomized study is still needed to confirm whether reducing radiation dose to the parotid ducts can meaningfully lower the risk of xerostomia and improve recovery after radiation treatment.
- Conditions
- Head and Neck Cancer
- Being tested
- MRI sialography, Parotid Duct Sparing Radiation Therapy Planning, Parotid Sparing Radiation Therapy Planning
- Keywords
- Radiation-induced xerostomia, parotid gland dose, radiation dose, parotd sparing, MRI sialography
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI sialographyDevice
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 PlanningOther
Radiation therapy will be administered based on treatment planning that aims to minimize the dose to the parotid ducts.
Parotid Sparing Radiation Therapy PlanningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: MRI sialography; Other: Parotid Sparing Radiation Therapy Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
Salivary flow unstimulated
Participants will be asked not to eat, drink (except water), or smoke for at least one hour before the test and will rinse their mouth with deionized water five minutes prior to collection.
Participants will sit comfortably with their head slightly forward and allow saliva to naturally accumulate in the mouth. They will spit into a pre-weighed cup every 60 seconds for five minutes. After a five-minute rest, stimulated saliva will be collected. Participants will chew paraffin gum for one minute at a controlled rate, then continue chewing and spit accumulated saliva into a separate pre-weighed cup every 60 seconds for five minutes.
Measured: at 6 and 12 months
Salivary flow stimulated
Stimulated saliva will be collected five-minute rest after the unstimulated saliva collection. Participants will chew paraffin gum for one minute at a controlled rate, then continue chewing and spit accumulated saliva into a separate pre-weighed cup every 60 seconds for five minutes.
Measured: at 6 and 12 months
The rate of xerostomia score based on the University of Michigan Xerostomia Questionnaire- 12 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.
Measured: 12 months
The rate of xerostomia score based on the MD Anderson Symptom Inventory Head and Neck (MDASI - HN)- 12 months
The rate of xerostomia will be assessed using the MD Anderson Symptom Inventory-Head and Neck (MDASI-HN), a validated patient-reported outcome measure evaluating symptom severity and impact on daily functioning in head and neck cancer patients. It includes 13 core symptom items (e.g., fatigue, pain, nausea), 9 head and neck-specific items (e.g., swallowing difficulty, dry mouth, taste changes, voice problems), and 6 interference items assessing effects on mood, work, and enjoyment of life. Each item is rated on a 0-10 scale, where 0 indicates no symptom or interference and 10 indicates the worst severity or complete interference. Scores are calculated as the mean of core symptom items for total severity, the mean of head and neck-specific items, and the mean of interference items.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start28 Jan 2026
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- David Fried, PhD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278557
- Sponsor's protocol ID
- LCCC2444-DCT
- Other IDs
- UG3DE033389
- Status last verified
- Oct 2026
- First submitted
- 3 Dec 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will be shared with other researchers per the NIHs data management and sharing policy.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia Following Radiotherapy for Oropharynx Cancer
- ClinicalTrials.gov ID
- NCT07278557
- Acronym / sponsor ID
- LCCC2444-DCT
- Conditions
- Head and Neck Cancer
- Keywords
- Radiation-induced xerostomia, parotid gland dose, radiation dose, parotd sparing, MRI sialography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Radiation-induced dry mouth (xerostomia) is the most commonly reported long-term side effect in patients receiving radiation therapy (RT) for head and neck cancer. It occurs when saliva production decreases and the saliva becomes thicker. Patients with xerostomia often have trouble chewing, swallowing, and speaking, and are more likely to develop tooth decay. These problems can significantly lower a patient's quality of life-and the impact tends to get worse over time.
The most common way to reduce radiation-related dry mouth is by limiting the average radiation dose to the parotid glands (which produce saliva). However, this is often not possible because of the patient's anatomy, and many patients still report moderate to severe symptoms long after treatment.
To reduce side effects, some studies have tested giving a lower radiation dose (60Gy instead of the usual 70Gy) in patients with low-risk, HPV-associated tumors. While this has helped improve overall symptoms, xerostomia still remains the most severe and persistent problem reported by patients.
New strategies are needed to better protect patients from radiation-related dry mouth and help maintain their quality of life after treatment. Recent research shows that the parotid gland does not respond evenly to radiation; certain areas, especially large salivary ducts where stem/progenitor cells live, may be key for recovery after damage. If these ducts can be located during treatment planning, the radiation dose to them could be reduced.
A pilot study showed that using MRI sialography to identify the parotid ducts and plan radiation therapy around them is both possible and promising. Patients who received this type of duct-sparing RT had fewer moderate-to-severe dry mouth symptoms compared to patients treated with standard RT (46% vs. 71% at 6 months, and 36% vs. 50% at 12 months post-treatment).
A larger, randomized study is still needed to confirm whether reducing radiation dose to the parotid ducts can meaningfully lower the risk of xerostomia and improve recovery after radiation treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Device: MRI sialography, Other: Parotid Duct Sparing Radiation Therapy PlanningParticipants 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. |
| Standard Arm | Active comparator | Device: MRI sialography, Other: Parotid Sparing Radiation Therapy PlanningParticipants 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- An individual who meets any of the following criteria will be excluded from participation
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI sialographyPrior 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 | Device | Experimental Arm, Standard Arm |
| Parotid Duct Sparing Radiation Therapy PlanningRadiation therapy will be administered based on treatment planning that aims to minimize the dose to the parotid ducts. | Other | Experimental Arm |
| Parotid Sparing Radiation Therapy PlanningRadiation 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. | Other | Standard Arm |
Primary outcome
The rate of xerostomia score based on the University of Michigan Xerostomia -6 months Questionnaire - 6 months
Time frame: 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.
4 secondary outcomes
Salivary flow unstimulated
Time frame: at 6 and 12 months
Salivary flow stimulated
Time frame: at 6 and 12 months
The rate of xerostomia score based on the University of Michigan Xerostomia Questionnaire- 12 months
Time frame: 12 months
The rate of xerostomia score based on the MD Anderson Symptom Inventory Head and Neck (MDASI - HN)- 12 months
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will be shared with other researchers per the NIHs data management and sharing policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Fried, PhD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MRI sialography, Parotid Duct Sparing Radiation Therapy Planning and Parotid Sparing Radiation Therapy Planning in people with Head and Neck Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuvara King ((984) 974-0000, tjking@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of xerostomia score based on the University of Michigan Xerostomia -6 months Questionnaire - 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.