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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03418792
• Other study ID #: LCCC 1735
• Status: Completed
• Phase: N/A
• Start date: March 8, 2018
• Est. completion date: May 2, 2023

Study information

• Verified date: May 2023
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2, 2023
• Est. primary completion date: April 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Oropharyngeal Neoplasms
• Oropharynx Cancer
• Xerostomia
• Xerostomia Due to Radiotherapy

Intervention

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.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill, Department of Radiation Oncology	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Xerostomia	Patient reported xerostomia (dry mouth) after IMRT with salivary ductal sparing	One year after completion of IMRT on last enrolled patient
Secondary	Salivary Ductal Visibility	Correlation between mean dose to individual salivary gland ducts and post-treatment visibility scores	One year after completion of IMRT on last enrolled patient
Secondary	Salivary Gland Volume	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
Secondary	Salivary Secretion Rate	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
Secondary	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	One year after completion of IMRT on last enrolled patient