TheraBionic P1 Device for Liver Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment device called the TheraBionic P1 for individuals with advanced liver cancer, specifically hepatocellular carcinoma (HCC), who lack other treatment options. The main goals are to determine if this device can extend patients' lives, ensure its long-term safety, and observe the cancer's response to treatment. Suitable participants are those with advanced liver tumors that cannot be treated locally or have recurred after local treatment and who have already tried at least two other cancer treatments without success. As an unphased trial, it provides a unique opportunity for patients to explore a novel treatment option when other avenues have been exhausted.
Will I have to stop taking my current medications?
If you are taking calcium channel blockers or similar medications, you will need to stop them before joining the trial and avoid them during the study. For other medications, the trial protocol does not specify any requirements.
What prior data suggests that the TheraBionic P1 device is safe for liver cancer patients?
Studies have shown that the TheraBionic P1 device is safe for patients with advanced liver cancer. Research indicates that even those with severely impaired liver function can use this treatment without major problems. In a study involving 69 patients, the device was used until the disease worsened or the patient passed away, and no major safety issues emerged. The treatment uses non-thermal radio waves, which are proven to be safe. Additionally, the TheraBionic P1 device has FDA approval for treating advanced hepatocellular carcinoma (a type of liver cancer), further confirming its safety.12345
Why are researchers excited about this trial?
Unlike traditional treatments for liver cancer, which often involve chemotherapy, radiation, or surgery, the TheraBionic P1 device offers a non-invasive approach. This device is unique because it uses amplitude-modulated electromagnetic fields, which patients can self-administer three times a day. Researchers are excited about its potential to offer a novel mechanism of action that targets cancer cells differently, potentially reducing side effects and improving patients' quality of life compared to conventional treatments.
What evidence suggests that the TheraBionic P1 device is effective for liver cancer?
Research has shown that the TheraBionic P1 device, which participants in this trial will use, might help people with advanced liver cancer live longer. Studies found that patients using this device experienced over a 30% increase in survival rates. On average, patients treated with TheraBionic lived about 9 months after other treatments stopped working. Another study reported an average survival of about 6.7 months, indicating varied outcomes. These findings suggest the device could help extend life for those with few other options.23456
Who Is on the Research Team?
Anthony F Shields, M.D.
Principal Investigator
Wayne State University
Are You a Good Fit for This Trial?
This trial is for individuals with advanced hepatocellular carcinoma (HCC), a type of liver cancer, who have no standard treatment options left. Specific eligibility criteria are not provided, but typically participants would need to be in stable health otherwise and able to comply with the study requirements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants self-administer the TheraBionic P1 device three times daily
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for overall survival and disease progression
What Are the Treatments Tested in This Trial?
Interventions
- TheraBionic P1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Barbara Ann Karmanos Cancer Institute
Lead Sponsor
THERABIONIC INC.
Collaborator