Gemcitabine, Nab-paclitaxel Plus the TheraBionic P1 (an Amplitude-Modulated Radiofrequency Electromagnetic Fields) Device to Treat Metastatic Pancreatic Cancer

Part of paid clinical trials in Clarkston, Michigan.

Sponsor
Barbara Ann Karmanos Cancer Institute
Study ID
NCT06576115
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nab paclitaxel — DRUG
    125 mg/m2 weekly, on days 1,8, and 15 or on days 1 and 15 as a 30-40 minute infusion administered first
  • Gemcitabine — DRUG
    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
  • TheraBionic P1 — DEVICE
    This treatment consists of delivering preset 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.

Study Details

The goal of this study is to learn if the combination of nab-paclitaxel, gemcitabine and an Amplitude-Modulated Radiofrequency Electromagnetic Fields device (Therabionic P1) is safe and effective for patients with adenocarcinoma of the pancreas.

Key Dates

Start date
Feb 28, 2025
Status verified
Nov 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gemcitabine/Nab-Paclitaxel plus TheraBionic Device
    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.

Primary Outcome Measure

6 Month Progression-Free Survival Rate (PFS 6) [ Time Frame: 6 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Karmanos Cancer Institute at McLaren ClarkstonClarkstonMichigan48346
Anthony F Shields, M.D., PhD
[email protected]
1-248-922-6650
Karmanos Cancer InstituteDetroitMichigan48021
Anthony F Shields, M.D. PhD
[email protected]
Anthony F Shields, M.D. PhD (PRINCIPAL_INVESTIGATOR)
Mohammed N Al Hallak, M.D. (SUB_INVESTIGATOR)
Wasif Saif, M.D. (SUB_INVESTIGATOR)
Karmanos Cancer Institute at McLaren FlintFlintMichigan48532
Anthony F Shields, M.D., PhD
[email protected]
1-810-342-3800
Karmanos Cancer Institute at McLaren Greater LansingLansingMichigan48910
Anthony F Shields, M.D., PhD
[email protected]
1-517-975-9500
Karmanos Cancer Institute at McLaren Lapeer RegionLapeerMichigan48446
Anthony F Shields, M.D., PhD
[email protected]
1-810-667-4994
Karmanos Cancer Institute at McLaren Northern Michigan, PetoskeyPetoskeyMichigan49770
Anthony F Shields, M.D., PhD
[email protected]
1-231-487-3390
Karmanos Cancer Institute at McLaren Port HuronPort HuronMichigan48060
Anthony F Shields, M.D., PhD
1-810-982-5200

Find similar trials in Clarkston, MI

By research site
Karmanos Cancer Institute at McLaren Clarkston· Clarkston, MIKarmanos Cancer Institute· Detroit, MIKarmanos Cancer Institute at McLaren Flint· Flint, MIKarmanos Cancer Institute at McLaren Greater Lansing· Lansing, MIKarmanos Cancer Institute at McLaren Lapeer Region· Lapeer, MIKarmanos Cancer Institute at McLaren Northern Michigan, Petoskey· Petoskey, MI

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