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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up 1 year

Awards & highlights

Study Summary

This trial studies the effects of a combination of chemo drugs & a device to treat pancreatic cancer.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up 1 year

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival

Secondary outcome measures

Disease Control Rate

Incidences of Adverse Events

Progression-Free Survival

+1 more

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

~70

Gemcitabine

2017

Completed Phase 3

~2070

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,242 Previous Clinical Trials

1,004,221 Total Patients Enrolled

8 Trials studying Adenocarcinoma

478 Patients Enrolled for Adenocarcinoma

TherabionicsOTHER

1 Previous Clinical Trials

166 Total Patients Enrolled

Ravi Paluri, MDPrincipal InvestigatorWake Forest Baptist Comprehensive Cancer Center

Media Library

Gemcitabine (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05776524 — Phase 2

Adenocarcinoma Research Study Groups: GEM-ABR [Gemcitabine - Abraxane (nab-Paclitaxel)] with TheraBionic device

Adenocarcinoma Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT05776524 — Phase 2

Gemcitabine (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05776524 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment period still open for this experiment?

"Per the clinicaltrials.gov listing, this medical experiment is no longer recruiting test subjects, having last been updated on 3rd August 2023 after first being posted on 6th June of that year. However, 719 alternative studies are currently accepting patients."

Answered by AI

What are the safety considerations associated with utilizing GEM-ABR in combination with TheraBionic technology?

"While there is some proof of safety, GEM-ABR with TheraBionic device only achieved a score of 2. This rating reflects the fact that it has yet to be proven effective as part of a Phase 2 trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields in Metastatic Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05776524.