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NCT03418792 · ClinicalTrials.gov registry record · NA
Functional Sparing of Salivary Glands Using MRI Sialography for Patients Undergoing Definitive Radiation Therapy for Head and Neck Cancers of the Oropharynx
A NA study of Head and Neck Cancer and Oropharynx Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT03418792: Completed NA study of Head and Neck Cancer and Oropharynx Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT03418792 is a NA study of Head and Neck Cancer and Oropharynx Cancer that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 40 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03418792, a NA study of Head and Neck Cancer and Oropharynx Cancer, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Primary Outcome
Patient reported xerostomia (dry mouth) after IMRT with salivary ductal sparing
Conditions Studied
Interventions
- OTHER Parotid-Sparing Head & Neck Radiation Guided by MRI Sialography
Study Locations (1)
North Carolina
- University of North Carolina at Chapel Hill, Department of Radiation Oncology - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-03-08 |
| Est. Completion | 2023-05-02 |
| Phase | NA |
What the finished NCT03418792 record still lists
NCT03418792 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (85% lower).
The record links to 3 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 1 intervention - of which Parotid-Sparing Head & Neck Radiation Guided by MRI Sialography is the first listed.
NCT03418792 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03418792 about?
NCT03418792 is a clinical study titled "Functional Sparing of Salivary Glands Using MRI Sialography for Patients Undergoing Definitive Radiation Therapy for Head and Neck Cancers of the Oropharynx". 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 ind...
What is the current status of trial NCT03418792?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2018-03-08. Estimated completion is 2023-05-02.
What conditions does trial NCT03418792 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Oropharynx Cancer, Xerostomia Due to Radiotherapy.
What interventions are being tested in trial NCT03418792?
The interventions under investigation include: Parotid-Sparing Head & Neck Radiation Guided by MRI Sialography (OTHER).
Who is sponsoring clinical trial NCT03418792?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03418792 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03418792's enrollment target sits among peer trials
40 142nd of 250 higher than 99 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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