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Chemotherapy

Chemotherapy + TheraBionic for Pancreatic Cancer

Phase 2

Recruiting

Led By Ravi Paluri, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have organ and marrow function as defined below: Organ and Marrow Function Absolute neutrophil count (ANC) ≥ 1,500/mcL Platelets* ≥ 100,000/mcL Hemoglobin* ≥ 7 g/dL *It is acceptable to transfuse packed red blood cells (PRBC) and platelets at the time of enrollment to meet the eligibility criteria. Total bilirubin ≤ 1.5 X institutional upper limit of normal AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal (≤ 5 x ULN, if liver metastasis) Creatinine ≤ 1.5 X institutional upper limit of normal Or CrCL > 50

Age 18 years old or greater.

Must not have

Patients receiving calcium channel blockers and any agent blocking L-type of T type Voltage Gated Calcium Channels such as amlodipine, nifedipine, ethosuximide are not allowed in the study unless their medical treatment is modified to exclude calcium channel blockers prior to enrollment.

Pregnant women are excluded from this study because of potential risk for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with chemotherapy and amplitude-modulated radiofrequency electromagnetic fields, patients who are breastfeeding will be excluded to participate in this study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for patients with advanced pancreatic cancer. The treatment combines two chemotherapy drugs with a device that emits radio waves. The goal is to see if this combination can improve survival rates and control the disease better than standard treatments.

Who is the study for?

This trial is for adults with newly diagnosed, untreated metastatic pancreatic adenocarcinoma. They should be in good physical condition (ECOG 0-1), have measurable tumors, and agree to use two forms of contraception if applicable. Exclusions include prior chemotherapy for metastasis, enrollment in other trials, certain heart medications, uncontrolled illnesses, recent major surgery, brain metastases or a history of severe allergies to the drugs being tested.

What is being tested?

The study examines the effects of standard chemotherapy (gemcitabine and nab-paclitaxel) combined with TheraBionic device treatment on patients with advanced pancreatic cancer. The goal is to assess how this combination influences the disease compared to traditional treatments alone.

What are the potential side effects?

Potential side effects may include reactions related to chemotherapy such as nausea, fatigue, hair loss and increased risk of infection. The TheraBionic device might cause unknown risks due to its novel approach using electromagnetic fields.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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Your blood counts, liver and kidney functions need to be within certain limits. If they are too low, you may need a blood transfusion to qualify.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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I have at least one tumor that can be measured on a scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking calcium channel blockers like amlodipine or nifedipine.

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I am not pregnant or breastfeeding.

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I have been diagnosed with a lung condition such as interstitial lung disease or pulmonary fibrosis.

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I do not have brain metastases.

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I do not have any severe illnesses or social situations that would make it hard for me to follow the study's requirements.

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My tumor can be surgically removed or is in an advanced local stage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival

Secondary study objectives

Disease Control Rate

Incidences of Adverse Events

Progression-Free Survival

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: GEM-ABR [Gemcitabine - Abraxane (nab-Paclitaxel)] with TheraBionic deviceExperimental Treatment3 Interventions

Metastatic pancreatic cancer patients will be treated with amplitude-modulated radiofrequency electromagnetic fields using TheraBionic device in combination with standard chemotherapy, gemcitabine- nab-paclitaxel. amplitude-modulated radiofrequency electromagnetic fields will be delivered by the TheraBionic device.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nab paclitaxel

2014

Completed Phase 2

~580

Gemcitabine

2017

Completed Phase 3

~1920