Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia

Not Applicable

Not yet recruiting

• Conditions: Head and Neck Cancer; Oropharynx Cancer; Xerostomia
• Interventions: Radiation: experimental radiotherapy; Radiation: standard radiotherapy

• Registration Number: NCT06276946
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-16
• Study First Submitted QC: 2024-02-23
• Study First Posted: 2024-02-26
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Study Start: 2025-05-08
• Primary Completion: 2028-07
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parotid Duct	experimental radiotherapy	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.
Mean Parotid	standard radiotherapy	Standard radiotherapy planning aims to restrict the mean parotid radiation dose to less than or equal to 14 Gy.

Primary Outcome Measures

Name	Time	Method
The difference in patient-reported xerostomia 6 months	6 months after completion of radiotherapy	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.

Secondary Outcome Measures

Name	Time	Method
Saliva mass	6 months and 12 months after completion of radiotherapy	The mass of generated saliva post-radiation treatment will be measured.
Parotid duct dose constraint	6 months after completion of radiotherapy	The efficacy of 14Gy parotid duct constraint for subjects undergoing parotid ductal sparing radiation therapy will be measured using patient-reported xerostomia scores.
The difference in patient-reported xerostomia 12 months	12 months after completion of radiotherapy	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. Each question is scaled from 0 to 10. 0= not present and 10= as bad as you imagine.
Xerostomia by NCI-CTCAE	12 months after completion of radiotherapy	xerostomia will be assessed using The National Cancer Institute Common Terminology Criteria for Adverse Events is a descriptive terminology (NCI-CTCAE) v5.0 that can be utilized for Adverse Event (AE) reporting.; A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill, Department of Radiation Oncology; 🇺🇸 Chapel Hill, North Carolina, United States