Ketogenic Diet in Treating Patients with Stage II-III Pancreatic Cancer Undergoing Chemoradiation Therapy

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Status: Closed to Accrual and Intervention

Description

This phase I trial studies the side effects of a ketogenic diet in treating patients with stage II-III pancreatic cancer undergoing chemoradiation therapy. Ketogenic diets have a very low level of carbohydrates (sugars) and may have good or bad effects during chemotherapy and radiation therapy.

Eligibility Criteria

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 American Joint Committee on Cancer (AJCC) as IIA, IIB, or III (T3 or T4, any N, M0)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky > 50%)
  • Hypertensive medication should be initiated or increased for optimal blood pressure control according to standard public health guidelines prior to starting the ketogenic diet
  • Leukocytes >= 3,000/mm^3
  • Absolute neutrophil count >= 1,500/mm^3
  • Platelets >= 100,000/mm^3
  • Total bilirubin < 3.0 mg/dl
  • Hemoglobin (Hgb) A1C =< 8%
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 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 m^2 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

Exclusion Criteria

  • Prior abdominal radiotherapy
  • Known G6PD (glucose-6-phosphate dehydrogenase) deficiency
  • Hyperuricemia, history of gout, high uric acid, and/or kidney disease
  • Patients on corticosteroids for any reason
  • 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

Locations & Contacts

See trial information on ClinicalTrials.gov for a list of participating sites.

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. Determine the safety of administering a ketogenic diet during concurrent gemcitabine (gemcitabine hydrochloride)-radiation therapy for the definitive treatment of non-resectable pancreatic cancer.

SECONDARY OBJECTIVES:

I. Quantify blood ketone levels via both finger-stick prior to daily radiation therapy and weekly lab analysis while on a ketogenic diet.

II. Quantify blood glucose levels via finger-stick prior to daily radiation therapy while on a ketogenic diet.

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

IV. Determine oxidative stress parameters in plasma and urine samples during the course of treatment.

OUTLINE:

Patients receive a ketogenic diet daily beginning a minimum of 2 days prior to and continuing for 5 weeks through chemoradiation therapy. Patients receive gemcitabine hydrochloride intravenously (IV) over 30-60 minutes once weekly for up to 6 weeks and undergo radiation therapy 5 days a week for approximately 5.5 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 3 months for 1 year.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
University of Iowa/Holden Comprehensive Cancer Center

Principal Investigator
Sudershan K. Bhatia

Trial IDs

Primary ID 201102772
Secondary IDs NCI-2012-00326, 01110101
Clinicaltrials.gov ID NCT01419483

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