Oropharynx CancerNCT06276946
Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia
A study testing standard radiotherapy and experimental radiotherapy in people with Oropharynx Cancer and 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 toxicities experienced by patients undergoing radiation treatment for head and neck cancer. Radiation-induced dry mouth is a frequently experienced symptom and persists after treatment, potentially indefinitely. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharynx Cancer, Head and Neck Cancer, Xerostomia
- What is being tested?
- standard radiotherapy and experimental radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2025to Jan 2029
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.
- Subjects is willing and able to comply with study procedures based on the judgment of the investigator.
- Age ≥ 18 years at the time of consent.
- T0-4, N0-3, M0 disease American Joint Committee on Cancer (AJCC 7th or 8th edition) of the oropharynx (this includes patients with head and neck cancer of unknown primary origin, often categorized as T0 disease, who will be treated with radiotherapy to the oropharynx) planned for definitive radiotherapy +/- chemotherapy
- 5 No contraindications to receiving MRI such as implanted electrical devices, pregnancy, and significant quantities of metal in the head/neck
Who cannot join
- Patients with Sjogren's syndrome or baseline xerostomia (CTCAE > 0 for the question regarding dry mouth)
- Patients with lesions grossly involving the salivary glands
- Patients with an allergy to lemon juice
- Prior history of radiation therapy to the head and neck
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, 27599
About this study
Official title: Randomized 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 toxicities experienced by patients undergoing radiation treatment for head and neck cancer. Radiation-induced dry mouth is a frequently experienced symptom and persists after treatment, potentially indefinitely. Current practice does not specifically attempt to spare the parotid ducts, where stem/progenitor cells are believed to preferentially reside, and considers the entire salivary gland to have equal function. New radiation therapy planning and conducting strategies are needed to reduce this toxicity and maximize patient quality of life post-treatment.
This randomized Phase II study explores the contribution of magnetic resonance imaging (MRI) guided salivary gland duct definition to decrease patient-reported xerostomia in patients with oropharynx cancer receiving radiation therapy. The severity of xerostomia will be measured by patient-reported (PRO) symptoms, saliva secretion, saliva pH, and buffering.
- Conditions
- Oropharynx Cancer, Head and Neck Cancer, Xerostomia
- Being tested
- standard radiotherapy, experimental radiotherapy
- Keywords
- radiotherapy, magnetic resonance imaging, parotis, parotid duct, radiotherapy dosimetry, radiotherapy planning
- Medical subject headings
- Oropharyngeal Neoplasms, Head and Neck Neoplasms, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard radiotherapyRadiation
radiotherapy planning goal is to restrict the mean parotid dose is equal to or less than 14Gy.
experimental radiotherapyRadiation
radiotherapy planning goal is to restrict the parotid duct dose is equal to or less than 14Gy
| Study group | Role | What they receive |
|---|---|---|
| Mean Parotid | Active comparator | Standard radiotherapy planning aims to restrict the mean parotid radiation dose to less than or equal to 14 Gy. Receives: Radiation: standard radiotherapy |
| Parotid Duct | Experimental | Magnetic resonance images will be used to localize the parotid ducts and limit the radiation dose to these structures to less than or equal to 14 Gy. Receives: Radiation: experimental radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in patient-reported xerostomia 6 months
The difference in patient-reported xerostomia will be assessed using the MD Anderson Symptom Inventory -Head \& Neck (MDASI-HN) questionnaire. MDASI multi-symptom patient-reported outcome (PRO) measure for clinical and research use. Use the MDASI to assess the severity of symptoms Each question is scaled from 0 to 10. 0= not present and 10= as bad as you imagine.
Measured: 6 months after completion of radiotherapy
Secondary outcomes (4)
Saliva mass
The mass of generated saliva post-radiation treatment will be measured.
Measured: 6 months and 12 months after completion of radiotherapy
Parotid duct dose constraint
The efficacy of 14Gy parotid duct constraint for subjects undergoing parotid ductal sparing radiation therapy will be measured using patient-reported xerostomia scores.
Measured: 6 months after completion of radiotherapy
The difference in patient-reported xerostomia 12 months
The difference in patient-reported xerostomia will be assessed using the MD Anderson Symptom Inventory -Head \& Neck (MDASI-HN) questionnaire. MDASI multi-symptom patient-reported outcome (PRO) measure for clinical and research use. Each question is scaled from 0 to 10. 0= not present and 10= as bad as you imagine.
Measured: 12 months after completion of radiotherapy
Xerostomia by NCI-CTCAE
xerostomia will be assessed using The National Cancer Institute Common Terminology Criteria for Adverse Events is a descriptive terminology (NCI-CTCAE) v5.0 that can be utilized for Adverse Event (AE) reporting.
A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Measured: 12 months after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start8 Aug 2025 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJan 2029 (estimated)
Why it stopped: Operational reason
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharynx 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Colette Shen, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276946
- Sponsor's protocol ID
- LCCC2244
- Status last verified
- Aug 2025
- First submitted
- 16 Feb 2024
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Assessment of Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia Following Radiotherapy for Oropharynx Cancer
- ClinicalTrials.gov ID
- NCT06276946
- Acronym / sponsor ID
- LCCC2244
- Conditions
- Oropharynx Cancer, Head and Neck Cancer, Xerostomia
- Keywords
- radiotherapy, magnetic resonance imaging, parotis, parotid duct, radiotherapy dosimetry, radiotherapy planning
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Operational reason
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 8 Aug 2025 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 26 Feb 2024 (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 toxicities experienced by patients undergoing radiation treatment for head and neck cancer. Radiation-induced dry mouth is a frequently experienced symptom and persists after treatment, potentially indefinitely. Current practice does not specifically attempt to spare the parotid ducts, where stem/progenitor cells are believed to preferentially reside, and considers the entire salivary gland to have equal function. New radiation therapy planning and conducting strategies are needed to reduce this toxicity and maximize patient quality of life post-treatment.
This randomized Phase II study explores the contribution of magnetic resonance imaging (MRI) guided salivary gland duct definition to decrease patient-reported xerostomia in patients with oropharynx cancer receiving radiation therapy. The severity of xerostomia will be measured by patient-reported (PRO) symptoms, saliva secretion, saliva pH, and buffering.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mean Parotid | Active comparator | Radiation: standard radiotherapyStandard radiotherapy planning aims to restrict the mean parotid radiation dose to less than or equal to 14 Gy. |
| Parotid Duct | Experimental | Radiation: experimental radiotherapyMagnetic resonance images will be used to localize the parotid ducts and limit the radiation dose to these structures to less than or equal to 14 Gy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.
- Subjects is willing and able to comply with study procedures based on the judgment of the investigator.
- Age ≥ 18 years at the time of consent.
- T0-4, N0-3, M0 disease American Joint Committee on Cancer (AJCC 7th or 8th edition) of the oropharynx (this includes patients with head and neck cancer of unknown primary origin, often categorized as T0 disease, who will be treated with radiotherapy to the oropharynx) planned for definitive radiotherapy +/- chemotherapy
- 5 No contraindications to receiving MRI such as implanted electrical devices, pregnancy, and significant quantities of metal in the head/neck
Key exclusion criteria (4 listed)
- Patients with Sjogren's syndrome or baseline xerostomia (CTCAE > 0 for the question regarding dry mouth)
- Patients with lesions grossly involving the salivary glands
- Patients with an allergy to lemon juice
- Prior 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 |
|---|---|---|
| standard radiotherapyradiotherapy planning goal is to restrict the mean parotid dose is equal to or less than 14Gy. | Radiation | Mean Parotid |
| experimental radiotherapyradiotherapy planning goal is to restrict the parotid duct dose is equal to or less than 14Gy | Radiation | Parotid Duct |
Primary outcome
The difference in patient-reported xerostomia 6 months
Time frame: 6 months after completion of radiotherapy
The difference in patient-reported xerostomia will be assessed using the MD Anderson Symptom Inventory -Head \& Neck (MDASI-HN) questionnaire. MDASI multi-symptom patient-reported outcome (PRO) measure for clinical and research use. Use the MDASI to assess the severity of symptoms Each question is scaled from 0 to 10. 0= not present and 10= as bad as you imagine.
4 secondary outcomes
Saliva mass
Time frame: 6 months and 12 months after completion of radiotherapy
Parotid duct dose constraint
Time frame: 6 months after completion of radiotherapy
The difference in patient-reported xerostomia 12 months
Time frame: 12 months after completion of radiotherapy
Xerostomia by NCI-CTCAE
Time frame: 12 months after completion of radiotherapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Colette Shen, MD 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 study testing standard radiotherapy and experimental radiotherapy in people with Oropharynx Cancer and 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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 5 Sep 2025. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in patient-reported xerostomia 6 months (time frame: 6 months after completion of radiotherapy). 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 5 Sep 2025.