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

NCT06576115 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-11-05

No results posted yet for this study

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.

Conditions

  • Metastatic Pancreatic 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

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 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.

Sponsors & Collaborators

  • Barbara Ann Karmanos Cancer Institute

    lead OTHER

Principal Investigators

  • Anthony F Shields, M.D. PhD · Barbara Ann Karmanos Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-28
Primary Completion
2027-07-31
Completion
2027-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06576115 on ClinicalTrials.gov