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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields in Metastatic Pancreatic Cancer (NCT05776524) is a Phase 2 interventional studying Pancreatic Cancer and Metastatic Adenocarcinoma, sponsored by THERABIONIC INC.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Pancreatic Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 46 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Patient must have newly diagnosed untreated biopsy proven metastatic adenocarcinoma of the pancreas. If a patient had a biopsy of the pancreatic mass and the clinical picture is consistent with metastatic pancreatic cancer, another biopsy of a metastatic site is not required for this trial. Pancreatic tumors with mixed histology that has predominant adenocarcinoma can be enrolled. - One or more measurable metastatic tumors per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) on imaging studies (CT or MRI) of chest, abdomen and pelvis. - Females of childbearing potential and males with female partners of childbearing potential, if sexually active, must agree to use two forms of contraception during the period of administration of study drug and up to 6 months after the end of treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. - Age 18 years old or greater. - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. - 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 \- Ability to understand and the willingness to sign an IRB-approved willing to sign a consent form document (either directly or via a legally authorized representative). Who Should NOT Join This Trial: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Patient must have newly diagnosed untreated biopsy proven metastatic adenocarcinoma of the pancreas. If a patient had a biopsy of the pancreatic mass and the clinical picture is consistent with metastatic pancreatic cancer, another biopsy of a metastatic site is not required for this trial. Pancreatic tumors with mixed histology that has predominant adenocarcinoma can be enrolled. * One or more measurable metastatic tumors per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) on imaging studies (CT or MRI) of chest, abdomen and pelvis. * Females of childbearing potential and males with female partners of childbearing potential, if sexually active, must agree to use two forms of contraception during the period of administration of study drug and up to 6 months after the end of treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * Age 18 years old or greater. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * 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 \- Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative). Exclusion Criteria: * Patients treated with any chemotherapy in metastatic setting and/or who had chemotherapy with gemcitabine and/or nab-paclitaxel within six months prior to entering the study in the adjuvant or neo-adjuvant setting are excluded. Patients who have had chemotherapy with FOLFIRINOX prior to entering the study in the adjuvant or neo-adjuvant setting can be enrolled into the study. * Patients with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * History of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine and nab-paclitaxel. * History of malignancy in last 3 years except cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated low risk prostate cancer, who are considered to be eligible. * 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. * Patients with active and uncontrolled bacterial, viral or fungal infection requiring systemic therapy. Patients can be reevaluated for the study if the infection is deemed to be under control and the systemic therapy is completed. * Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or could compromise patient safety. * Known diagnosis of interstitial lung disease, sarcoidosis, pulmonary fibrosis or pneumonitis. * 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. * Localized resectable or locally advanced tumor. * Undergone surgery, other than diagnostic surgery or minor procedures, within 4 weeks prior to the treatment day. * Unable to comply with study procedures or anticipating a situation that would result in a treatment break for 14 or more consecutive days after the start of the study. * Actively enrolled in any other clinical interventional trial or receiving any other investigational agents.

Treatments Being Tested

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

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)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05776524), the sponsor (THERABIONIC INC.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05776524 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05776524?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05776524?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05776524. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05776524. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.