Ketogenic Diet With Concurrent Chemoradiation For Pancreatic Cancer

Study Overview

Ketogenic Diet With Concurrent Chemoradiation for Pancreatic Cancer

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

Pancreatic Neoplasms

DIETARY_SUPPLEMENT: Ketogenic diet

201102772
1R21CA161182 (U.S. NIH Grant/Contract)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-07-28	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-01-04
First Submitted that Met QC Criteria 2011-08-16	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-01-08
First Posted (ACTUAL) 2011-08-18	Results First Posted N/A	Last Verified 2018-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Ketogenic diet 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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Ketogenic diet

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.

Primary Outcome Measures	Measure Description	Time Frame
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

Secondary Outcome Measures	Measure Description	Time Frame
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.	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.	Daily during treatment for 6 weeks
Oxidative stress parameters	Determine oxidative stress parameters in plasma and urine samples during the course of treatment.	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.	Every 12 months for 60 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Patients must have a cytological or histological diagnosis of adenocarcinoma arising in the pancreas. Adenosquamous cancers will be acceptable.
Cancer should be staged via AJCC as IIA, IIB, or III (T3 or T4, any N, M0)
Age ≥ 18 years
ECOG performance status 0-2 (Karnofsky > 50%, see Appendix A).
Hypertensive medication should be initiated or increased for optimal blood pressure control according to standard public health guidelines prior to starting the ketogenic diet.
Patients must have normal organ and marrow function as defined below:
leukocytes ≥ 3,000/mm3
absolute neutrophil count ≥ 1,500/mm3
platelets ≥ 100,000/mm3
total bilirubin < 3.0 mg/dl
Hgb A1C < or = to 8%
AST(SGOT) < or = 5 X institutional upper limit of normal OR a stable or a decreasing test value in patients who have undergone placement of an intrabiliary stent. Both the treating radiation oncologist and medical oncologist must agree that the potential subject's test value is acceptable for study accrual.
creatinine < 1.5 X institutional upper limit of normal OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
Not pregnant. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Ability to understand and the willingness to sign a written informed consent document.

Prior abdominal radiotherapy.
Prior therapy, with the intent to treat, the current diagnosis of pancreatic cancer.
Known G6PD (glucose-6-phosphate dehydrogenase) deficiency.
Patients on corticosteroids for any reason.
Living alone at time of diet initiation.
Other investigational agents/therapy with the intention to treat the disease under study (observational or imaging trials are acceptable).
Uncontrolled diabetes defined as a hemoglobin A1C level > 8% (therapeutic action is indicated at greater than 8%).
Diabetes mellitus is not exclusionary provided the patient is not maintained with either oral medications or insulin.
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situations, or any other condition that would limit compliance with study requirements as determined by study team members.
Pregnant or lactating women: The risks of radiation and chemotherapy to a fetus are well documented.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Institutes of Health (NIH)
National Cancer Institute (NCI)
Nutricia North America

Investigators

PRINCIPAL_INVESTIGATOR: Bryan G. Allen, MD, PhD, The Department of Radiation Oncology, The University of Iowa

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Zahra A, Fath MA, Opat E, Mapuskar KA, Bhatia SK, Ma DC, Rodman SN III, Snyders TP, Chenard CA, Eichenberger-Gilmore JM, Bodeker KL, Ahmann L, Smith BJ, Vollstedt SA, Brown HA, Hejleh TA, Clamon GH, Berg DJ, Szweda LI, Spitz DR, Buatti JM, Allen BG. Consuming a Ketogenic Diet while Receiving Radiation and Chemotherapy for Locally Advanced Lung Cancer and Pancreatic Cancer: The University of Iowa Experience of Two Phase 1 Clinical Trials. Radiat Res. 2017 Jun;187(6):743-754. doi: 10.1667/RR14668.1. Epub 2017 Apr 24.

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