NCT03578432

Everolimus in Restoring Salivary Gland Function in Participants With Locally Advanced Head and Neck Cancer Treated With Radiation Therapy

Clinical Evaluation of Everolimus (a Rapamycin Analog) in Restoring Salivary Gland Function to Patients Treated With Radiotherapy for Head and Neck Cancer

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This early phase 1 trial studies the use of everolimus in restoring salivary gland function in participants with locally advanced head and neck cancer after concurrent chemoradiation or radiation therapy alone.

Detailed description

PRIMARY OBJECTIVES: I. To describe the recovery of salivary gland function after administration of a 5-day course of everolimus, administered two weeks after completion of radiation or chemoradiation therapy. SECONDARY OBJECTIVES: I. To describe the decrease of saliva flow rates during radiation or chemoradiation therapy. II. To describe the changes in saliva protein composition during radiation or chemoradiation therapy and following administration of a 5-day course of everolimus. OUTLINE: This is an early phase 1 proof of principal study. Participants receive everolimus orally (PO) once daily (QD) for 5 days beginning 2 weeks after completion of radiation or chemoradiation treatment. Participants also undergo saliva output testing at baseline prior to radiation or chemoradiation treatment, after 3 weeks of RT/chemoRT, after 6 weeks of RT/chemoRT, prior to everolimus administration, at completion of the 5 day everolimus course, and at 1, 3, and 6 months after the completion of radiation or chemoradiation therapy.

Conditions

• Salivary Gland Dysfunction
• Xerostomia
• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Everolimus	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2018-05-04
• Primary completion: 2019-11-15
• Completion: 2019-11-15
• First posted: 2018-07-06
• Last updated: 2019-12-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study