NCT01419483

Ketogenic Diet With Concurrent Chemoradiation for Pancreatic Cancer

A Phase I Trial of a Ketogenic Diet With Concurrent Chemoradiation for Pancreatic Cancer.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Pancreatic Neoplasms

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ketogenic diet	A ketogenic diet matching the fat to carbohydrate + proteins in Keto-Cal(R) 4:1 by Nutricia North America.

Timeline

• Start date: 2011-07-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2011-08-18
• Last updated: 2018-01-08

Locations

1 site across 1 country: United States