Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia

Head and Neck Cancer Clinical Trial

Official title:

Randomized Assessment of Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia Following Radiotherapy for Oropharynx Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06276946
• Other study ID #: LCCC2244
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 8, 2024
• Est. completion date: January 2029

Study information

• Verified date: June 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: Melissa Knutsen, MPH
• Phone: (919) 445-4869
• Email: melissa_knutsen[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 98
• Est. completion date: January 2029
• Est. primary completion date: July 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

In order to participate in this study a subject must meet all of the eligibility criteria outlined below. Eligibility must be maintained up for the subject to be considered eligible for treatment.

Inclusion Criteria

1. Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.

2. Subjects is willing and able to comply with study procedures based on the judgment of the investigator.

3. Age = 18 years at the time of consent.

4. 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

5 No contraindications to receiving MRI such as implanted electrical devices, pregnancy, and significant quantities of metal in the head/neck

Exclusion Criteria

1. Patients with Sjogren's syndrome or baseline xerostomia (CTCAE > 0 for the question regarding dry mouth)

2. Patients with lesions grossly involving the salivary glands

3. Patients with an allergy to lemon juice

4. Prior history of radiation therapy to the head and neck

Related Conditions & MeSH terms

• Head and Neck Cancer
• Oropharyngeal Neoplasms
• Oropharynx Cancer
• Xerostomia

Intervention

Radiation:
• standard radiotherapy
radiotherapy planning goal is to restrict the mean parotid dose is equal to or less than 14Gy.
• experimental radiotherapy
radiotherapy planning goal is to restrict the parotid duct dose is equal to or less than 14Gy

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	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	Saliva mass	The mass of generated saliva post-radiation treatment will be measured.	6 months and 12 months after completion of radiotherapy
Secondary	Parotid duct dose constraint	The efficacy of 14Gy parotid duct constraint for subjects undergoing parotid ductal sparing radiation therapy will be measured using patient-reported xerostomia scores.	6 months after completion of radiotherapy
Secondary	The difference in patient-reported xerostomia 12 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. Each question is scaled from 0 to 10. 0= not present and 10= as bad as you imagine.	12 months after completion of radiotherapy
Secondary	Xerostomia by NCI-CTCAE	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.	12 months after completion of radiotherapy

External Links

•   University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials