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

Phase 1
18 Years
Open (Enrolling)
Pancreatic Neoplasms

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Trial Information

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

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

- 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

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

Female and male patients of all ethnic groups will be eligible for treatment in these

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency of Adverse Events (Safety)

Outcome Description:

Categorize and quantify adverse events in subjects implementing a ketogenic diet while undergoing definitive chemoradiation therapy.

Outcome Time Frame:

Weekly for 8 weeks

Safety Issue:


Principal Investigator

Sudershan K Bhatia, MD, MPH, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Department of Radiation Oncology, The University of Iowa


United States: Food and Drug Administration

Study ID:




Start Date:

July 2011

Completion Date:

July 2015

Related Keywords:

  • Pancreatic Neoplasms
  • Pancreatic neoplasms
  • Pancreatic cancer
  • Ketogenic Diet
  • radiotherapy
  • gemcitabine
  • Neoplasms
  • Pancreatic Neoplasms



Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009