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

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ClinicalTrials.gov Identifier: NCT03418792
Recruitment Status : Active, not recruiting
First Posted : February 1, 2018
Last Update Posted : October 12, 2021
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Description
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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. 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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
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
Actual Primary Completion Date : April 22, 2021
Estimated Study Completion Date : March 2022

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Arms and Interventions
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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.


Outcome Measures
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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

  3. 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

  4. 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


Eligibility Criteria
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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 disease of the oropharynx
  • Will be treated with IMRT and with definitive intent (either definitive or postoperative radiotherapy)
  • No contraindications to receiving an 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 (CT imaging of the chest or PET/CT is acceptable)
  • 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
Contacts and Locations
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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


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
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Principal Investigator: David V. Fried, PhD University of North Carolina at Chapel Hill, Department of Radiation Oncology
More Information
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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03418792    
Other Study ID Numbers: LCCC 1735
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: October 12, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Oropharyngeal Neoplasms
Xerostomia
Neoplasms by Site
Neoplasms
Salivary Gland Diseases
 Mouth Diseases
Stomatognathic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Otorhinolaryngologic Diseases