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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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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:Select...
I do not have any severe illnesses like serious heart conditions.
Select...
I have not had major surgery in the last 4 weeks, except for a port-a-cath insertion.
Select...
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.
Select...
I have been diagnosed with Type 1 diabetes.
Select...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival per RECIST 1.1
Secondary outcome measures
Cancer Biomarkers
Cancer Biomarkers returning to normal
Change in BMI
+6 moreTrial 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.
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Who is running the clinical trial?
Translational Drug DevelopmentLead Sponsor
18 Previous Clinical Trials
980 Total Patients Enrolled
Translational Genomics Research InstituteOTHER
35 Previous Clinical Trials
106,997 Total Patients Enrolled
Brittany Porter, MPHStudy DirectorTranslational Drug Development
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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 have signs of cancer that has spread to the brain or spinal cord.You are expected to live for at least 12 more weeks.I have been cancer-free for over 2 years, except for specific non-threatening cancers.Your blood's ability to clot is within the normal range, or slightly above it. If you are taking blood-thinning medication, the doctor may decide if you can still participate in the study.My blood and organ functions are within normal ranges.My BMI is below 18, indicating severe malnutrition.I can follow the study's rules on birth control and pregnancy testing.I have not had major surgery in the last 4 weeks, except for a port-a-cath insertion.I haven't had treatments for my metastatic pancreatic disease yet.I have been diagnosed with Type 1 diabetes.Your albumin levels are lower than 3.0 g/dL.My pancreatic cancer has spread and hasn't been treated yet.I will not have unprotected sex during and for 6 months after the study.I am able to care for myself but may not be able to do active work.I am 18 years old or older.I have been diagnosed with HIV, hepatitis B, or hepatitis C.
Research Study Groups:
This trial has the following groups:- Group 1: Ketogenic (KD) + Triplet
- Group 2: Non-ketogenic + Triplet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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