Low-Sugar Diet in Treating Patients With Stage II-III Pancreatic Cancer Undergoing Chemoradiation Therapy

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Status: Closed to Accrual and Intervention

Description

The purpose of this research study is to determine the effects, good and bad, that using a special diet has on you during chemotherapy and radiation therapy for pancreatic cancer. If the diet is tolerated, we will open studies to see if using the diet improves the survival of pancreatic cancer patients. The diet is a ketogenic diet. It is has a very low level of carbohydrates (sugars). Most calories in the diet come from protein and fat.

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
  • 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

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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