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Spots Global Cancer Trial Database for Ketogenic Diet With Concurrent Chemoradiation for Pancreatic Cancer

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Ketogenic Diet With Concurrent Chemoradiation for Pancreatic Cancer

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

Study ID: NCT01419483

Interventions

Ketogenic diet

Study Description

Brief 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

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Holden Comprehensive Cancer Center, Iowa City, Iowa, United States

Contact Details

Name: Bryan G. Allen, MD, PhD

Affiliation: The Department of Radiation Oncology, The University of Iowa

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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