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| ID | Type | Description | Link |
|---|---|---|---|
| TR79005KCI00019 | Other Grant/Funding Number | U Can-Cer Vive | |
| AM-001 | Other Identifier | TheraBionic |
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| Name | Class |
|---|---|
| THERABIONIC INC. | OTHER |
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The goal of this clinical trial is to learn if the TheraBionic P1 device given to patients with advanced hepatocellular carcinoma (HCC) who have no standard of care options can affect patients survival. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TheraBionic P1 device | Experimental | Self administered Amplitude-modulated electromagnetic fields three times daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TheraBionic P1 | Device | Amplitude-modulated electromagnetic fields will be self-administered and given continuously to patients in three 60-minute treatments per day, administered in the morning, middle of the day, and in the evening |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival assessment will be recorded in days and will represent the period starting at the date of treatment initiation and finishing at the date of patient death from any cause. Living patients at the time of analysis will have the date of last contact (consultation visit or phone contact) used to define overall survival | From start of treatment until death, up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Measures of Pain Interference | National Institutes of Health Patient Reported Outcome Measurement Information System (PROMIS) measures of Pain Interference short form 4a. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more pain interference (poorer health). 4 items | From Start of Treatment to the end of treatment up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anthony F Shields, M.D. | Contact | 313-576-8735 | shieldsa@karmanos.org |
| Name | Affiliation | Role |
|---|---|---|
| Anthony F Shields, M.D. | Wayne State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karmanos Cancer Institute at McLaren Bay Region | Recruiting | Bay City | Michigan | 48706 | United States |
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| Patient-reported outcomes (PRO) | Patient-reported outcomes (PRO) measures will assess the trajectory of patient rated tolerability of treatment (Functional Assessment of Cancer Therapy items regarding bother of side effects, one item), patient-rated symptomatic adverse events (11 Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events item library items) | From Start of Treatment to the end of treatment up to 12 months |
| PROMIS Measures of Pain Intensity | NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of Pain Intensity short form 1a. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more pain intensity (poorer health). 1 item | From Start of Treatment to the end of treatment up to 12 months |
| ECOG Performance Status | (ECOG)Eastern Cooperative Oncology Group performance status scale to measure functional status and ability to carry out activities of daily living. A system used to assess how a patient's cancer or other serious illness affects their daily living abilities. It's a 6-point scale (0-5) where lower scores indicate better function and higher scores indicate more limitations | From Start of Treatment to the end of treatment up to 12 months |
| Disease Control Rate | Disease control will be defined as the percentage of patients who are alive and have documented response status of complete response (CR), partial response (PR) or stable disease (SD) at 4 months and 6 months from the date of enrollment. | From enrollment up to 6 months |
| Duration of overall response | Measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). The duration of overall complete response is measured from the time measurement criteria are first met for CR until the first date that recurrent disease is objectively documented. Duration of stable disease: Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started | From start of treatment up to 24 months |
| Time to Progression (TTP) | Time-to-radiological progression assessment will be recorded in days and will represent the period starting at the date of treatment initiation and finishing at the date of radiological assessment documenting tumor progression. Patients who initiate post-study anticancer therapy or die without documented progression will be censored at that time point. | Start of treatment to death from any cause up to 24 months |
| Progression-free survival (PFS) | Progression-free survival assessment will be recorded in days and will represent the period starting at the date of treatment initiation and finishing at the later of the date of documentation of radiologic tumor progression, date of last follow-up on study treatment or death, whichever comes first. Patients who initiate post-study antitumor therapy prior to radiologic progression will be censored for PFS at that date. | Start of treatment to progression of disease, last follow-up on study or death, whichever comes first up to 24 months |
| PROMIS Measures of Physical Function | National Institutes of Health Patient Reported Outcome Measurement Information System (PROMIS) measures of physical function short form 4a. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates less physical function (poorer health). 4 items | From Start of Treatment to the end of treatment up to 12 months |
| Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
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| Karmanos Cancer Institute at McLaren Flint | Recruiting | Flint | Michigan | 48532 | United States |
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| Karmanos Cancer Institute at McLaren Greater Lansing | Recruiting | Lansing | Michigan | 48910 | United States |
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| Karmanos Cancer Institute at McLaren Lapeer Region | Recruiting | Lapeer | Michigan | 48446 | United States |
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| Karmanos Cancer Institute at McLaren Central Michigan, Morey Cancer Center | Recruiting | Mount Pleasant | Michigan | 48858 | United States |
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