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Study of Chemotherapy and TheraBionic Device for Metastatic Pancreatic Cancer

This study is looking at how a combination of standard chemotherapy drugs, nab-paclitaxel and gemcitabine, along with a device called TheraBionic, affects people with newly diagnosed metastatic pancreatic adenocarcinoma (cancer that has spread from the pancreas). The TheraBionic device delivers low levels of radio waves into your body using a spoon-shaped antenna placed in your mouth for an hour, three times a day. The main goal is to see if this combination improves how long people live after 6 months. To join, you must have newly diagnosed, untreated metastatic pancreatic adenocarcinoma. The study plans to enroll 46 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 46 participants. It is evaluating the effects of combining standard chemotherapy with a device.
What's involved
You would receive nab-paclitaxel and gemcitabine infusions weekly or bi-weekly. You would also use the TheraBionic device three times a day for an hour each time.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, overall survival, will be measured at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05776524

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
THERABIONIC INC.
~46 participants
Updated 2025-03-25 on ClinicalTrials.gov
What's tested:Nab paclitaxelGemcitabineTheraBionic

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival
Measured over At 6 months

Conditions

Pancreatic Cancer
Metastatic Adenocarcinoma

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NCT05776524

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolinastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ravi Paluri, MD · PRINCIPAL_INVESTIGATOR · Wake Forest Baptist Comprehensive Cancer Center

Who to contact

Study Coordinator
[email protected]
3367136912
Email the study team

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Eligibility criteria

Inclusion

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:

Exclusion

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.

What this trial measures

  • Overall SurvivalAt 6 months

    Overall survival is defined from the time of study treatment initiation until death of any cause. Six months overall survival (OS 6) is defined as the proportion of patients alive at six months from treatment initiation. All participant demographic and clinical characteristics will be summarized using mean (standard deviation) and count (percent) for continuous and categorical variables, respectively. Primary analysis will calculate the overall survival rate at 6-months with one-sided 95% confidence interval