RecruitingPhase 2NCT05776524

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


Sponsor

THERABIONIC INC.

Enrollment

46 participants

Start Date

Jun 13, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing amplitude-modulated radiofrequency electromagnetic fields (AM RF EMF) — a non-invasive device therapy that uses specific radio wave frequencies — combined with standard chemotherapy (gemcitabine and nab-paclitaxel) for people with newly diagnosed metastatic pancreatic cancer. The device is worn on the body and emits targeted electromagnetic waves that may slow cancer growth. **You may be eligible if...** - You have newly diagnosed, untreated metastatic pancreatic adenocarcinoma (confirmed by biopsy) - You have at least one measurable metastatic tumor on imaging - You are well enough to receive chemotherapy - You agree to use contraception if applicable **You may NOT be eligible if...** - You have received prior treatment for metastatic pancreatic cancer - You have certain implanted devices (e.g., pacemakers) that may be affected by electromagnetic fields - You are pregnant or breastfeeding - You have severe organ dysfunction 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.

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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

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.


Locations(1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

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NCT05776524


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