Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields in Metastatic Pancreatic Cancer
NCT05776524 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2025-03-25
Summary
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.
Conditions
- Pancreatic Cancer
- Metastatic Adenocarcinoma
Interventions
- DRUG
-
Nab paclitaxel
125 mg/m2 weekly, on days 1,8, and 15 or on days 1 and 15 as a 30-40 minute infusion administered first
- DRUG
-
1000 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
- DEVICE
-
TheraBionic
This 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.
Sponsors & Collaborators
-
Therabionics
collaborator OTHER -
THERABIONIC INC.
lead OTHER
Principal Investigators
-
Ravi Paluri, MD · Wake Forest Baptist Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-13
- Primary Completion
- 2027-07-31
- Completion
- 2029-07-31
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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