A Phase I Trial of a Ketogenic Diet With Concurrent Chemoradiation for Pancreatic Cancer.
Standard treatment for pancreatic cancer includes chemotherapy concurrent with radiation
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.
- 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
- Have urine collected sporadically through the study to determine measurements of
- Keep a diary of concomitant medications, side effects, and blood sugars
- Have follow-up to monitor for outcomes and overall survival
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Frequency of Adverse Events (Safety)
Categorize and quantify adverse events in subjects implementing a ketogenic diet while undergoing definitive chemoradiation therapy.
Weekly for 8 weeks
Sudershan K Bhatia, MD, MPH, PhD
The Department of Radiation Oncology, The University of Iowa
United States: Food and Drug Administration
|Holden Comprehensive Cancer Center||Iowa City, Iowa 52242-1009|