Functional Sparing of Salivary Glands Using MRI Sialography for Patients Undergoing Definitive Radiation Therapy for Head and Neck Cancers of the Oropharynx

May 30, 2023 updated by: UNC Lineberger Comprehensive Cancer Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill, Department of Radiation Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parotid-Sparing Head & Neck Radiation
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.
Other: Parotid-Sparing Head & Neck Radiation Guided by MRI Sialography
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Xerostomia
Time Frame: One year after completion of IMRT on last enrolled patient
Patient reported xerostomia (dry mouth) after IMRT with salivary ductal sparing
One year after completion of IMRT on last enrolled patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary Ductal Visibility
Time Frame: One year after completion of IMRT on last enrolled patient
Correlation between mean dose to individual salivary gland ducts and post-treatment visibility scores
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
Correlation between mean dose to individual salivary gland ducts and post-treatment salivary gland volume
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
Correlation between mean dose to individual salivary gland ducts and post-treatment saliva secretion rate
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
Comparison of salivary secretion recovery rate after IMRT with salivary ductal sparing compared to current literature, particularly when irradiated glands exceed conventional dose constraints
One year after completion of IMRT on last enrolled patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Investigators

  • Principal Investigator: David V. Fried, PhD, University of North Carolina at Chapel Hill, Department of Radiation Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2018

Primary Completion (Actual)

April 22, 2022

Study Completion (Actual)

May 2, 2023

Study Registration Dates

First Submitted

January 25, 2018

First Submitted That Met QC Criteria

January 25, 2018

First Posted (Actual)

February 1, 2018

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCC 1735

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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