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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

Primary Purpose

Head and Neck Cancer, Oropharynx Cancer, Xerostomia Due to Radiotherapy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parotid-Sparing Head & Neck Radiation Guided by MRI Sialography
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Parotid-Sparing Head & Neck Radiation

Arm Description

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.

Outcomes

Primary Outcome Measures

Xerostomia
Patient reported xerostomia (dry mouth) after IMRT with salivary ductal sparing

Secondary Outcome Measures

Salivary Ductal Visibility
Correlation between mean dose to individual salivary gland ducts and post-treatment visibility scores
Salivary Gland Volume
Correlation between mean dose to individual salivary gland ducts and post-treatment salivary gland volume
Salivary Secretion Rate
Correlation between mean dose to individual salivary gland ducts and post-treatment saliva secretion rate
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

Full Information

First Posted
January 25, 2018
Last Updated
May 30, 2023
Sponsor
UNC Lineberger Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03418792
Brief Title
Functional Sparing of Salivary Glands Using MRI Sialography for Patients Undergoing Definitive Radiation Therapy for Head and Neck Cancers of the Oropharynx
Official Title
Functional Sparing of Salivary Glands Using MRI Sialography for Patients Undergoing Definitive Radiation Therapy for Head and Neck Cancers of the Oropharynx
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 8, 2018 (Actual)
Primary Completion Date
April 22, 2022 (Actual)
Study Completion Date
May 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Oropharynx Cancer, Xerostomia Due to Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parotid-Sparing Head & Neck Radiation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Parotid-Sparing Head & Neck Radiation Guided by MRI Sialography
Intervention Description
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 Measure Information:
Title
Xerostomia
Description
Patient reported xerostomia (dry mouth) after IMRT with salivary ductal sparing
Time Frame
One year after completion of IMRT on last enrolled patient
Secondary Outcome Measure Information:
Title
Salivary Ductal Visibility
Description
Correlation between mean dose to individual salivary gland ducts and post-treatment visibility scores
Time Frame
One year after completion of IMRT on last enrolled patient
Title
Salivary Gland Volume
Description
Correlation between mean dose to individual salivary gland ducts and post-treatment salivary gland volume
Time Frame
One year after completion of IMRT on last enrolled patient
Title
Salivary Secretion Rate
Description
Correlation between mean dose to individual salivary gland ducts and post-treatment saliva secretion rate
Time Frame
One year after completion of IMRT on last enrolled patient
Title
Salivary Secretion Recovery
Description
Comparison of salivary secretion recovery rate after IMRT with salivary ductal sparing compared to current literature, particularly when irradiated glands exceed conventional dose constraints
Time Frame
One year after completion of IMRT on last enrolled patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David V. Fried, PhD
Organizational Affiliation
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill, Department of Radiation Oncology
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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