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: * Utilize a specialized ketogenic diet designed by bionutritional services of the clinical research unit. This diet begins 2 days before chemoradiation and continues through at least 5 weeks of chemoradiation. * Have blood drawn for research purposes weekly to determine measurements of oxidative stress * Have urine collected sporadically through the study to determine measurements of oxidative stress * Keep a diary of concomitant medications, side effects, and blood sugars * Have follow-up to monitor for outcomes and overall survival
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
A ketogenic diet matching the fat to carbohydrate + proteins in Keto-Cal(R) 4:1 by Nutricia North America.
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
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
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