Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields in Metastatic Pancreatic Cancer
Part of paid clinical trials in Winston-Salem, North Carolina.
- Sponsor
- THERABIONIC INC.
- Study ID
- NCT05776524
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Metastatic Adenocarcinoma
- Pancreatic Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nab paclitaxel — DRUG125 mg/m2 weekly, on days 1,8, and 15 or on days 1 and 15 as a 30-40 minute infusion administered first
- Gemcitabine — DRUG1000 mg/m2 weekly, on day 1,8 and 15 or 1000 mg/m2 weekly, on day 1 and 15 over 30 minutes after nab- paclitaxel infusion
- TheraBionic — DEVICEThis treatment consists of delivering low levels of radio waves into the body with a spoon-shaped antenna placed in the mouth, three times a day, for an hour each time.
Study Details
The objective of this research is to find out what effects (good and bad), the combination of gemcitabine and nab-paclitaxel therapy (GEM-ABR for the rest of the document), standard chemotherapy for pancreatic cancer, and the TheraBionic device has on participants' condition.
Key Dates
- Start date
- Jun 13, 2023
- Status verified
- Mar 2025
- Primary completion
- Jul 31, 2027
- Completion
- Jul 31, 2029
Study Design
- Enrollment
- 46 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: GEM-ABR [Gemcitabine - Abraxane (nab-Paclitaxel)] with TheraBionic deviceMetastatic pancreatic cancer patients will be treated with amplitude-modulated radiofrequency electromagnetic fields using TheraBionic device in combination with standard chemotherapy, gemcitabine- nab-paclitaxel. amplitude-modulated radiofrequency electromagnetic fields will be delivered by the TheraBionic device.
Primary Outcome Measure
Overall Survival [ Time Frame: At 6 months ]
Central Contacts
- Study Coordinator3367136912
- Ravi Paluri, MD
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | Ravi K Paluri, MD (PRINCIPAL_INVESTIGATOR) |
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