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Golden Halo, Static Magnetic and Electric Field Device, in Recurrent Glioblastoma

Glioblastoma Clinical Trial

Official title:
Feasibility Study of a Static Magnetic and Electric Field Device in Adults With Recurrent Glioblastoma and Their Partners

Clinical Trial Summary

A prospective, open label, single-center, early feasibility trial will be conducted to assess the safety and feasibility of a home-based Static Magnetic and Electric (sBE) device applied for 8 hours/day during sleep in adult participants with recurrent glioblastoma (rGBM) at their first relapse.

Clinical Trial Description

The purpose of this research study is to test the feasibility of a Static Magnetic and Electric Field (sBE) Device when combined with standard chemotherapy drugs, Lomustine and Bevacizumab, in the treatment of patients with recurrent glioblastoma. The sBE device produces static magnetic (sB) and electric (sE) fields and is to be used 8 hours a day by the patients, during sleep, for 8 weeks, while also receiving standard chemotherapy Lomustine and Bevacizumab. Patients will have visits in clinic every two weeks during the treatment period. The visits will include MRI scans, quality of life assessments, neurological and physical exams, and blood draws. After the sBE treatment period, patients will continue standard chemotherapy with their regular oncologists. Partners of the patients, who sleep in the same beds, will be invited to participate and will be involved in the study procedures except for those intended to monitor the disease. If partners do not agree to participate, they will not be able to sleep in the devices. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05410301
Study type Interventional
Source University of Iowa
Contact
Status Withdrawn
Phase N/A
Start date April 2023
Completion date August 2026
View Details
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