Head and Neck CancerNCT03418792
Functional Sparing of Salivary Glands Using MRI Sialography for Patients Undergoing Definitive Radiation Therapy for Head and Neck Cancers of the Oropharynx
A study testing Parotid-Sparing Head & Neck Radiation Guided by MRI Sialography in people with Head and Neck Cancer and Oropharynx Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The proposed study is an attempt to improve patient xerostomia (dry mouth) after definitive radiation therapy treatment for head and neck cancer. Xerostomia is a frequently experienced symptom for those receiving radiation therapies to the head and neck that persists after treatment, potentially indefinitely. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Oropharynx Cancer, Xerostomia Due to Radiotherapy
- What is being tested?
- Parotid-Sparing Head & Neck Radiation Guided by MRI Sialography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2018to 2 May 2023
- 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
- At least 18 years of age
- T0-4, N0-3, M0 disease of the oropharynx
- Will be treated with intensity modulated radiation therapy (IMRT) and with definitive intent (either definitive or postoperative radiotherapy)
- No contraindications to receiving an magnetic resonance imaging (MRI) such as: implanted electrical devices, pregnancy, and/or significant quantities of metal in the head/neck
- Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to treatment; at a minimum, chest x-ray is required (computerized tomography (CT) imaging of the chest or positron emission tomography (PET) /CT is acceptable)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Able to comply with the treatment plan and follow-up schedule
- Provides study-specific informed consent prior to study entry
Who cannot join
- Sjogren's syndrome or baseline xerostomia (CTCAE > 0 for question regarding dry mouth)
- Lesions grossly involving the salivary glands
- Allergy to lemon juice
- Prior history of radiation therapy to the head and neck
- Pre-treatment scan deemed not usable
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
The proposed study is an attempt to improve patient xerostomia (dry mouth) after definitive radiation therapy treatment for head and neck cancer. Xerostomia is a frequently experienced symptom for those receiving radiation therapies to the head and neck that persists after treatment, potentially indefinitely. It has been shown that stem/progenitor cells preferentially reside in large ducts of salivary glands and that these cells have the ability to repair radiation induced salivary damage. Current practice does not specifically attempt to spare these regions and considers the entire salivary gland to have equal importance and function. This study will involve the acquisition of pre-treatment MRI sialogram images which enable visualization of salivary ducts (using saliva itself as a contrast agent) that can then be avoided during radiation treatment planning. Saliva samples will also be collected at this time to quantify baseline saliva secretion and saliva characteristics. The primary objective will be to obtain patient reported outcomes (PRO) measure of xerostomia related symptoms for comparison with a historical cohort. Xerostomia symptom information will be obtained by use of a patient reported quality of life survey administered prior to treatment and at 6, 12, 18, and 24 months after treatment. The secondary objectives will be to quantitatively assess post-treatment changes in saliva secretion, salivary gland volume, and ductal visibility using MRI sialograms. The target sample size for this study is 40 patients. The investigator hypothesizes that reducing the dose to these stem cell containing salivary ducts will facilitate improvements in patient reported symptoms as well as improved recovery of salivary secretion, salivary gland volume, and intra-glandular ductal visibility using MRI sialograms.
- Being tested
- Parotid-Sparing Head & Neck Radiation Guided by MRI Sialography
- Medical subject headings
- Head and Neck Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parotid-Sparing Head & Neck Radiation Guided by MRI SialographyOther
Head \& neck radiation with parotid sparing. Parotid sparing will be facilitated by avoidance of salivary ductal structures and stem cells, as identified by the pre-treatment MRI sialogram, in the radiation treatment plan.
| Study group | Role | What they receive |
|---|---|---|
| Parotid-Sparing Head & Neck Radiation | Experimental | Patients with Oropharyngeal Squamous Cell Carcinoma (OPSCC) who will be treated with parotid-sparing head \& neck radiation. MRI Sialograms will be obtained to identify salivary ductal structures and stem cells to be spared during treatment. Receives: Other: Parotid-Sparing Head & Neck Radiation Guided by MRI Sialography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Xerostomia
Patient reported xerostomia (dry mouth) after IMRT with salivary ductal sparing
Measured: One year after completion of IMRT on last enrolled patient
Secondary outcomes (4)
Salivary Ductal Visibility
Correlation between mean dose to individual salivary gland ducts and post-treatment visibility scores
Measured: One year after completion of IMRT on last enrolled patient
Salivary Gland Volume
Correlation between mean dose to individual salivary gland ducts and post-treatment salivary gland volume
Measured: One year after completion of IMRT on last enrolled patient
Salivary Secretion Rate
Correlation between mean dose to individual salivary gland ducts and post-treatment saliva secretion rate
Measured: One year after completion of IMRT on last enrolled patient
Salivary Secretion Recovery
Comparison of salivary secretion recovery rate after IMRT with salivary ductal sparing compared to current literature, particularly when irradiated glands exceed conventional dose constraints
Measured: One year after completion of IMRT on last enrolled patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start8 Mar 2018
- Primary completion22 Apr 2022
- Study completion2 May 2023
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David V. Fried, PhD, Principal investigator, University of North Carolina at Chapel Hill, Department of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418792
- Sponsor's protocol ID
- LCCC 1735
- Status last verified
- May 2023
- First submitted
- 25 Jan 2018
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Sparing of Salivary Glands Using MRI Sialography for Patients Undergoing Definitive Radiation Therapy for Head and Neck Cancers of the Oropharynx
- ClinicalTrials.gov ID
- NCT03418792
- Acronym / sponsor ID
- LCCC 1735
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 1 Feb 2018 (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.
The proposed study is an attempt to improve patient xerostomia (dry mouth) after definitive radiation therapy treatment for head and neck cancer. Xerostomia is a frequently experienced symptom for those receiving radiation therapies to the head and neck that persists after treatment, potentially indefinitely. It has been shown that stem/progenitor cells preferentially reside in large ducts of salivary glands and that these cells have the ability to repair radiation induced salivary damage. Current practice does not specifically attempt to spare these regions and considers the entire salivary gland to have equal importance and function. This study will involve the acquisition of pre-treatment MRI sialogram images which enable visualization of salivary ducts (using saliva itself as a contrast agent) that can then be avoided during radiation treatment planning. Saliva samples will also be collected at this time to quantify baseline saliva secretion and saliva characteristics. The primary objective will be to obtain patient reported outcomes (PRO) measure of xerostomia related symptoms for comparison with a historical cohort. Xerostomia symptom information will be obtained by use of a patient reported quality of life survey administered prior to treatment and at 6, 12, 18, and 24 months after treatment. The secondary objectives will be to quantitatively assess post-treatment changes in saliva secretion, salivary gland volume, and ductal visibility using MRI sialograms. The target sample size for this study is 40 patients. The investigator hypothesizes that reducing the dose to these stem cell containing salivary ducts will facilitate improvements in patient reported symptoms as well as improved recovery of salivary secretion, salivary gland volume, and intra-glandular ductal visibility using MRI sialograms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parotid-Sparing Head & Neck Radiation | Experimental | Other: Parotid-Sparing Head & Neck Radiation Guided by MRI SialographyPatients with Oropharyngeal Squamous Cell Carcinoma (OPSCC) who will be treated with parotid-sparing head \& neck radiation. MRI Sialograms will be obtained to identify salivary ductal structures and stem cells to be spared during treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least 18 years of age
- T0-4, N0-3, M0 disease of the oropharynx
- Will be treated with intensity modulated radiation therapy (IMRT) and with definitive intent (either definitive or postoperative radiotherapy)
- No contraindications to receiving an magnetic resonance imaging (MRI) such as: implanted electrical devices, pregnancy, and/or significant quantities of metal in the head/neck
- Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to treatment; at a minimum, chest x-ray is required (computerized tomography (CT) imaging of the chest or positron emission tomography (PET) /CT is acceptable)
Key exclusion criteria (5 listed)
- Sjogren's syndrome or baseline xerostomia (CTCAE > 0 for question regarding dry mouth)
- Lesions grossly involving the salivary glands
- Allergy to lemon juice
- Prior history of radiation therapy to the head and neck
- Pre-treatment scan deemed not usable
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 |
|---|---|---|
| Parotid-Sparing Head & Neck Radiation Guided by MRI SialographyHead \& neck radiation with parotid sparing. Parotid sparing will be facilitated by avoidance of salivary ductal structures and stem cells, as identified by the pre-treatment MRI sialogram, in the radiation treatment plan. | Other | Parotid-Sparing Head & Neck Radiation |
Primary outcome
Xerostomia
Time frame: One year after completion of IMRT on last enrolled patient
Patient reported xerostomia (dry mouth) after IMRT with salivary ductal sparing
4 secondary outcomes
Salivary Ductal Visibility
Time frame: One year after completion of IMRT on last enrolled patient
Salivary Gland Volume
Time frame: One year after completion of IMRT on last enrolled patient
Salivary Secretion Rate
Time frame: One year after completion of IMRT on last enrolled patient
Salivary Secretion Recovery
Time frame: One year after completion of IMRT on last enrolled patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
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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.
David V. Fried, PhD principal investigator
University of North Carolina at Chapel Hill, Department of Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parotid-Sparing Head & Neck Radiation Guided by MRI Sialography in people with Head and Neck Cancer and Oropharynx 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 5 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: finished, as of the sponsor's last update on 31 May 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Xerostomia (time frame: One year after completion of IMRT on last enrolled patient). 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 31 May 2023.