Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia

NCT06276946 | Withdrawn DMC FDA Device

• 1 other identifier: LCCC2244
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Radiation-induced xerostomia (dry mouth) is one of the most common and severe toxicities experienced by patients undergoing radiation treatment for head and neck cancer. Radiation-induced dry mouth is a frequently experienced symptom and persists after treatment, potentially indefinitely. Current practice does not specifically attempt to spare the parotid ducts, where stem/progenitor cells are believed to preferentially reside, and considers the entire salivary gland to have equal function. New radiation therapy planning and conducting strategies are needed to reduce this toxicity and maximize patient quality of life post-treatment. This randomized Phase II study explores the contribution of magnetic resonance imaging (MRI) guided salivary gland duct definition to decrease patient-reported xerostomia in patients with oropharynx cancer receiving radiation therapy. The severity of xerostomia will be measured by patient-reported (PRO) symptoms, saliva secretion, saliva pH, and buffering.

Conditions

Oropharynx Cancer; Head and Neck Cancer; Xerostomia

Keywords

radiotherapy; magnetic resonance imaging; parotis; parotid duct; radiotherapy dosimetry; radiotherapy planning

Outcome Measures

Primary Outcomes (1)

• The difference in patient-reported xerostomia 6 months

  The difference in patient-reported xerostomia will be assessed using the MD Anderson Symptom Inventory -Head \& Neck (MDASI-HN) questionnaire. MDASI multi-symptom patient-reported outcome (PRO) measure for clinical and research use. Use the MDASI to assess the severity of symptoms Each question is scaled from 0 to 10. 0= not present and 10= as bad as you imagine.

  6 months after completion of radiotherapy

Secondary Outcomes (4)

• Saliva mass

  6 months and 12 months after completion of radiotherapy

• Parotid duct dose constraint

  6 months after completion of radiotherapy

• The difference in patient-reported xerostomia 12 months

  12 months after completion of radiotherapy

• Xerostomia by NCI-CTCAE

  12 months after completion of radiotherapy

Study Arms (2)

Mean Parotid

ACTIVE COMPARATOR

Standard radiotherapy planning aims to restrict the mean parotid radiation dose to less than or equal to 14 Gy.

Radiation: standard radiotherapy

Parotid Duct

EXPERIMENTAL

Magnetic resonance images will be used to localize the parotid ducts and limit the radiation dose to these structures to less than or equal to 14 Gy.

Radiation: experimental radiotherapy

Interventions

standard radiotherapy RADIATION

radiotherapy planning goal is to restrict the mean parotid dose is equal to or less than 14Gy.

Mean Parotid

experimental radiotherapy RADIATION

radiotherapy planning goal is to restrict the parotid duct dose is equal to or less than 14Gy

Parotid Duct

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.
• Subjects is willing and able to comply with study procedures based on the judgment of the investigator.
• Age ≥ 18 years at the time of consent.
• T0-4, N0-3, M0 disease American Joint Committee on Cancer (AJCC 7th or 8th edition) of the oropharynx (this includes patients with head and neck cancer of unknown primary origin, often categorized as T0 disease, who will be treated with radiotherapy to the oropharynx) planned for definitive radiotherapy +/- chemotherapy
• No contraindications to receiving MRI such as implanted electrical devices, pregnancy, and significant quantities of metal in the head/neck

You may not qualify if:

• Patients with Sjogren's syndrome or baseline xerostomia (CTCAE \> 0 for the question regarding dry mouth)
• Patients with lesions grossly involving the salivary glands
• Patients with an allergy to lemon juice
• Prior history of radiation therapy to the head and neck

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

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

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Head and Neck Neoplasms; Xerostomia

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Salivary Gland Diseases; Mouth Diseases

Study Officials

• Colette Shen, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: February 26, 2024
• Study Start: August 8, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)