Actively Recruiting
Treatment of Patients With Metastatic Pancreatic Cancer Using Gemcitabine, Nab-Paclitaxel, and Amplitude-Modulated Radiofrequency Electromagnetic Fields Device
Led by Barbara Ann Karmanos Cancer Institute ยท Updated on 2025-11-05
30
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining nab-paclitaxel, gemcitabine, and the TheraBionic P1 device, which delivers amplitude-modulated radiofrequency electromagnetic fields, for patients with metastatic pancreatic adenocarcinoma. This phase 2 study focuses on whether this combined treatment can improve outcomes for those with advanced pancreatic cancer. The trial is sponsored by the Barbara Ann Karmanos Cancer Institute and aims to assess progression-free survival over six months. Participants receive standard chemotherapy with gemcitabine and nab-paclitaxel given via infusion on a weekly schedule, either on days 1, 8, and 15 or days 1 and 15 of each treatment cycle. Alongside chemotherapy, patients use the TheraBionic P1 device, which involves placing a spoon-shaped antenna in the mouth to deliver low levels of radio waves three times daily for one hour each session. This combined treatment approach is studied throughout the trial period. During the study, participants undergo imaging scans such as CT, MRI, or PET to measure tumor response and identify measurable metastatic tumors. Researchers monitor progression-free survival at six months as the primary outcome, alongside secondary measures including adverse events, overall survival, and disease control rates up to one year. Safety and treatment effects are closely observed to understand the impact of this combined therapy over time.
CONDITIONS
Brief Title
Gemcitabine, Nab-paclitaxel Plus the TheraBionic P1 (an Amplitude-Modulated Radiofrequency Electromagnetic Fields) Device to Treat Metastatic Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have proven advanced metastatic adenocarcinoma of the pancreas or mixed tumor with predominant adenocarcinoma
- One or more measurable metastatic tumors confirmed by CT, MRI, or PET scans
- Female patients of childbearing potential must have a negative pregnancy test within 48 hours before chemotherapy
- Sexually active participants with partners of childbearing potential must use two forms of contraception during treatment and for 6 months after
- Age above 18 years
- Patients 80 years and older must undergo thorough evaluation and be clinically stable
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate blood counts and organ function as defined by specific laboratory values
- Ability and willingness to provide informed consent
You will not qualify if you...
- Prior chemotherapy with gemcitabine or nab-paclitaxel within 6 months before study entry
- Use of other investigational agents
- Known brain metastases
- History of allergic reactions to gemcitabine or nab-paclitaxel or similar compounds
- History of malignancy within last 3 years except certain treated cancers
- Use of calcium channel blockers or other excluded medications unless modified before enrollment
- Active uncontrolled infections requiring systemic therapy
- Uncontrolled illnesses such as heart failure or psychiatric conditions limiting compliance
- Diagnosis of interstitial lung disease, sarcoidosis, pulmonary fibrosis, or pneumonitis
- Pregnant or breastfeeding women
- Localized resectable or locally advanced tumors
- Major surgery within 4 weeks before treatment
- Inability to comply with study procedures or anticipated treatment breaks of 14 days or more
- Enrollment in other clinical interventional trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive chemotherapy with gemcitabine and nab-paclitaxel combined with the TheraBionic P1 device treatment. The device delivers low levels of radio waves through a spoon-shaped antenna placed in the mouth three times daily for one hour each time.
Weekly visits for chemotherapy administration; device treatment occurs three times daily at home
Duration - Up to 6 months after treatment
Participants are monitored for disease progression, overall survival, and adverse events after treatment completion.
Regular follow-up visits up to 6 months
Trial Site Locations
Total: 7 locations
1
Karmanos Cancer Institute at McLaren Clarkston
Clarkston, Michigan, United States, 48346
Actively Recruiting
2
Karmanos Cancer Institute
Detroit, Michigan, United States, 48021
Actively Recruiting
3
Karmanos Cancer Institute at McLaren Flint
Flint, Michigan, United States, 48532
Actively Recruiting
4
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, United States, 48910
Actively Recruiting
5
Karmanos Cancer Institute at McLaren Lapeer Region
Lapeer, Michigan, United States, 48446
Actively Recruiting
6
Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey
Petoskey, Michigan, United States, 49770
Actively Recruiting
7
Karmanos Cancer Institute at McLaren Port Huron
Port Huron, Michigan, United States, 48060
Actively Recruiting
Research Team
A
Anthony F Shields, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here