Ketogenic Diet for Pancreatic Cancer

Recruiting at 6 trial locations

Overseen By Khara Stemley

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Translational Drug Development

Disqualifiers: CNS metastasis, HIV, Hepatitis B, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 21

Duration: 36 months

32 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate the effects of the ketogenic diet in patients with metastatic pancreatic cancer while receiving chemotherapy.

Research Team

Steve Norton, MBA PhD

Principal Investigator

Translational Drug Development

Eligibility Criteria

This trial is for adults with metastatic pancreatic ductal adenocarcinoma who haven't been treated for their advanced disease. They must be able to perform daily activities (KPS ≥ 70%), have a life expectancy of at least 12 weeks, and measurable tumor lesions. Participants need a smartphone or computer, acceptable blood counts and organ function, and agree to use contraception if necessary. Excluded are those with severe malnutrition, certain heart conditions, recent major surgery, uncontrolled illnesses or infections.

Inclusion Criteria

Your tumors can be measured using specific guidelines called RECIST 1.1.

I do not have severe numbness or pain in my hands or feet.

You are expected to live for at least 12 more weeks.

Exclusion Criteria

I do not have any severe illnesses like serious heart conditions.

I have had diabetic ketoacidosis in the past.

I do not have any ongoing serious infections needing treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a ketogenic or non-ketogenic diet along with triplet chemotherapy (nab-paclitaxel, cisplatin, gemcitabine) administered intravenously on Days 1 and 8 every 21 days

36 months

Visits every 21 days for chemotherapy administration

Follow-up

Participants are monitored for progression-free survival, changes in serum metabolites, quality of life, and other secondary outcomes

36 months

Treatment Details

Interventions

• Ketogenic Diet

Trial Overview The study tests the ketogenic diet's effects on patients with advanced pancreatic cancer while they undergo chemotherapy. The goal is to see how this high-fat, low-carbohydrate diet might influence cancer treatment outcomes.

Participant Groups

Group I: Ketogenic (KD) + Triplet Experimental Treatment 1 Intervention

Ketogenic diet plus nab-paclitaxel 125 mg/m2, cisplatin 25 mg/m2, and gemcitabine 1000 mg/m2 all administered intravenously (IV) on Days 1 and 8 every 21 days.

Group II: Non-ketogenic + Triplet Active Control 1 Intervention

Non-ketogenic diet plus nab-paclitaxel 125 mg/m2, cisplatin 25 mg/m2, and gemcitabine 1000 mg/m2 all administered intravenously (IV) on Days 1 and 8 every 21 days.

Who Is Running the Clinical Trial?

Translational Drug Development

Lead Sponsor

Trials

19

Recruited

1,000+

Translational Genomics Research Institute

Collaborator

Trials

36

Recruited

107,000+