NCT05776524

Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields in Metastatic Pancreatic Cancer

A Phase 2 Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields in Metastatic Pancreatic Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: THERABIONIC INC. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objective(s): The primary objective of this study is to evaluate the efficacy of the combination of nab-paclitaxel, gemcitabine, and amplitude-modulated radiofrequency electromagnetic fields in improving 6-month overall survival (OS) rates in patients with metastatic adenocarcinoma of the pancreas. Secondary Objective(s): * Evaluate the safety and tolerability of the combination of nab-paclitaxel, gemcitabine, and amplitude-modulated radiofrequency electromagnetic fields in patients with metastatic adenocarcinoma of the pancreas. * Evaluate progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines in patients with metastatic adenocarcinoma of the pancreas treated with the combination of nab-paclitaxel, gemcitabine, and amplitude-modulated radiofrequency electromagnetic fields. * Evaluate the objective response rate (ORR) in patients with metastatic adenocarcinoma of the pancreas treated with the combination of nab-paclitaxel, gemcitabine, and amplitude-modulated radiofrequency electromagnetic fields. * Evaluate the disease control rate (DCR) in patients with metastatic adenocarcinoma of the pancreas treated with the combination of nab-paclitaxel, gemcitabine, and amplitude-modulated radiofrequency electromagnetic fields.

Conditions

• Pancreatic Cancer
• Metastatic Adenocarcinoma

Interventions

Type	Name	Description
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	Gemcitabine	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.

Timeline

• Start date: 2023-06-13
• Primary completion: 2027-07-01
• Completion: 2029-07-01
• First posted: 2023-03-20
• Last updated: 2025-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study