Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03418792
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Brief 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. 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, six months after treatment, and one year after treatment. The secondary objectives will be to quantitatively assess post-treatment changes in salivary gland volume as well as ductal visibility using MRI sialograms. The study team hopes to acquire pre- and post-treatment images from 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 gland volume and intra-glandular ductal visibility using MRI sialograms.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Oropharynx Cancer Xerostomia Due to Radiotherapy Other: Parotid-Sparing Head & Neck Radiation Guided by MRI Sialography Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Functional Sparing of Salivary Glands Using MRI Sialography for Patients Undergoing Definitive Radiation Therapy for Head and Neck Cancers of the Oropharynx
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Xerostomia [ Time Frame: One year after completion of IMRT on last enrolled patient ]
    Patient reported xerostomia (dry mouth) after IMRT with salivary ductal sparing


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • T0-4, N0-3, M0 squamous cell carcinoma of the oropharynx
  • Will be treated with IMRT and with definitive intent (either definitive or postoperative radiotherapy)
  • Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to treatment; at a minimum, chest x-ray is required (CT imaging of the chest or PET/CT is acceptable)
  • ECOG Performance Status 0-2
  • Negative pregnancy test within 2 weeks prior to treatment for women of childbearing potential
  • Able to comply with the treatment plan and follow-up schedule
  • Able to provide study-specific informed consent provided prior to study entry

Exclusion Criteria:

  • Any contraindications to receiving an MRI such as: implanted electrical devices, pregnancy, and/or significant quantities of metal in the head/neck
  • Sjorgen'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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418792


Contacts
Layout table for location contacts
Contact: David V. Fried, PhD 984-974-8717 david_fried@med.unc.edu
Contact: Emily C. Goldman, BS 984-974-8441 emily_goldman@med.unc.edu

Locations
Layout table for location information
United States, North Carolina
University of North Carolina at Chapel Hill, Department of Radiation Oncology Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: David V. Fried, PhD    984-974-8717    david_fried@med.unc.edu   
Contact: Emily C. Goldman, BS    984-974-8441    emily_goldman@med.unc.edu   
Principal Investigator: David V. Fried, PhD         
Sub-Investigator: Bhishamjit Chera, MD         
Sub-Investigator: Shiva Das, PhD         
Sub-Investigator: Benjamin Huang, MD         
Sub-Investigator: Colette Shen, MD, PhD         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: David V. Fried, PhD University of North Carolina at Chapel Hill, Department of Radiation Oncology

Layout table for additonal information
Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03418792     History of Changes
Other Study ID Numbers: LCCC 1735
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Xerostomia
Mouth Diseases
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Neoplasms by Site
Neoplasms
Salivary Gland Diseases
Stomatognathic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Otorhinolaryngologic Diseases