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Ketogenic Diet for Pancreatic Cancer

N/A

Waitlist Available

Research Sponsored by Translational Drug Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

<Grade 2 pre-existing peripheral neuropathy per NCI CTCAE, Version 5.0

Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma, not previously treated for their metastatic disease

Must not have

Uncontrolled intercurrent illness, including but not limited to New York Heart Association Class III or IV, myocardial infarction within the past 6 months, or unstable arrhythmia

Major surgery within 4 weeks prior to study entry. (Port-a-cath may be inserted during this time period)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether the ketogenic diet can help cancer patients with chemotherapy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from following a ketogenic diet may include fatigue, nausea, constipation or diarrhea due to dietary changes. There could also be an increased risk of nutrient deficiencies without careful monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My pancreatic cancer has spread and hasn't been treated yet.

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I am able to care for myself but may not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have not had major surgery in the last 4 weeks, except for a port-a-cath insertion.

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I have had diabetic ketoacidosis in the past.

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I do not have any ongoing serious infections needing treatment.

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My BMI is below 18, indicating severe malnutrition.

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I have been diagnosed with Type 1 diabetes.

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I have been diagnosed with HIV, hepatitis B, or hepatitis C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival per RECIST 1.1

Secondary study objectives

Cancer Biomarkers

Cancer Biomarkers returning to normal

Change in BMI

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Ketogenic (KD) + TripletExperimental Treatment1 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 + TripletActive Control1 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.

0 / 10Eligibility criteria met