An interventional study of Ketogenic diet in Pancreatic Neoplasms, sponsored by University of Iowa. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-08.
Sponsored by University of Iowa · Not applicable, Interventional, and Treatment
This study investigates if using a very low carbohydrate diet during combined chemotherapy and radiation therapy is safe and if it can be tolerated by patients.
Standard treatment for pancreatic cancer includes chemotherapy concurrent with radiation therapy (chemoradiation).
This study is a phase I trial to determine the safety of dietary manipulation during chemoradiation for pancreatic cancer. Specifically, pre-clinical data from mouse studies indicates a ketogenic diet increases tumor cell killing.
Participants will:
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 5 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →University of Iowa is the lead sponsor of 276 studies on the registry; 35 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 39 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Female and male patients of all ethnic groups will be eligible for treatment in these protocols.
Diet designed to maintain elevated ketone levels during therapy
Dietary Supplement: Ketogenic diet
A ketogenic diet matching the fat to carbohydrate + proteins in Keto-Cal(R) 4:1 by Nutricia North America.
Frequency of Adverse Events (Safety)
Categorize and quantify adverse events in subjects implementing a ketogenic diet while undergoing definitive chemoradiation therapy.
Time frame: Weekly for 8 weeks
Ketone levels
Quantify blood ketone levels via both finger-stick prior to daily radiation therapy and weekly lab analysis while on a ketogenic diet. Radiation is administered Monday through Friday only.
Time frame: Daily during treatment for 6 weeks
Blood glucose levels
Quantify blood glucose levels via finger-stick prior to daily radiation therapy while on a ketogenic diet. Radiation therapy is administered Monday through Friday only.
Time frame: Daily during treatment for 6 weeks
Oxidative stress parameters
Determine oxidative stress parameters in plasma and urine samples during the course of treatment.
Time frame: Weeks 1, 2, 3, 4, 5, and 6 of treatment and at 1 month follow-up
Progression Free Survival (months)
From date of treatment until the first date of documented progression or date of death, whichever comes first, assessed no less than every 12 months for the first 60 months post-therapy.
Time frame: Every 12 months for 60 months
This study is terminated, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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University of Iowa