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

  • Resize font
  • Print
  • Email
  • Facebook
  • Twitter
  • Google+
  • Pinterest

Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IBiomarker/Laboratory analysis, Treatment18 and over201102772
NCI-2012-00326, 01110101, NCT01419483

Trial Description

Summary

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.

Further Study Information

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.

Eligibility Criteria

Inclusion Criteria:

Ability to understand and the willingness to sign a written informed consent document

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

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

Hemoglobin (Hgb) A1C =< 8%

Total bilirubin < 3.0 mg/dl

Leukocytes >= 3,000/mm^3

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 a cytological or histological diagnosis of adenocarcinoma arising in the pancreas; adenosquamous cancers will be acceptable

Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky > 50%)

Platelets >= 100,000/mm^3

Absolute neutrophil count >= 1,500/mm^3

Cancer should be staged via American Joint Committee on Cancer (AJCC) as IIA, IIB, or III (T3 or T4, any N, M0)

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

Exclusion Criteria:

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

Uncontrolled diabetes defined as a hemoglobin A1C level > 8% (therapeutic action is indicated at greater than 8%)

Other investigational agents/therapy with the intention to treat the disease under study (observational or imaging trials are acceptable)

Living alone at time of diet initiation

Patients on corticosteroids for any reason

Known G6PD (glucose-6-phosphate dehydrogenase) deficiency

Prior abdominal radiotherapy

Pregnant or lactating women; the risks of radiation and chemotherapy to a fetus are well documented

Diabetes mellitus is not exclusionary provided the patient is not maintained with either oral medications or insulin

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

University of Iowa/Holden Comprehensive Cancer Center

  • National Cancer Institute
Sudershan K. Bhatia, Principal Investigator

Trial Sites

U.S.A.

Iowa
Iowa City

University of Iowa/Holden Comprehensive Cancer Center

Sudershan K. Bhatia
Ph: 319-356-7609
Email: sudershan-bhatia@uiowa.edu

Sudershan K. Bhatia
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01419483

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.