RecruitingPhase 2NCT06576115

Gemcitabine, Nab-paclitaxel Plus the TheraBionic P1 (an Amplitude-Modulated Radiofrequency Electromagnetic Fields) Device to Treat Metastatic Pancreatic Cancer

Treatment of Patients With Metastatic Pancreatic Cancer With Gemcitabine and Nab-Paclitaxel and Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF)

Sponsor

Barbara Ann Karmanos Cancer Institute

Enrollment

30 participants

Start Date

Feb 28, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Pancreatic Adenocarcinoma

Summary

The goal of this study is to learn if the combination of nab-paclitaxel, gemcitabine and an Amplitude-Modulated Radiofrequency Electromagnetic Fields device (Therabionic P1) is safe and effective for patients with adenocarcinoma of the pancreas.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a wearable device that delivers low-level radiofrequency waves (the TheraBionic P1) to standard chemotherapy improves outcomes for people with advanced pancreatic cancer that has spread to other parts of the body. **You may be eligible if...** - You have been confirmed by biopsy to have advanced pancreatic cancer (adenocarcinoma) that has spread - You have at least one measurable tumor on a scan - You have adequate organ function (liver, kidneys, bone marrow) - You have not received prior chemotherapy for this cancer (treatment-naive) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have active brain metastases - You have a serious infection or uncontrolled medical condition - You have received prior systemic treatment for this pancreatic cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNab 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

DRUGGemcitabine

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

DEVICETheraBionic P1

This treatment consists of delivering preset 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.