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Clinical Trials (PDQ®)

Ketogenic Diet With Concurrent Chemoradiation for Pancreatic Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IBiomarker/Laboratory analysis, TreatmentActive18 and overNCI, Other201102772
1R21CA161182, NCT01419483

Trial Description

Summary

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.

Further Study Information

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

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 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.

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 protocols.

Trial Contact Information

Trial Lead Organizations/Sponsors

Holden Comprehensive Cancer Center at University of Iowa

National Cancer Institute

National Cancer Institute

Nutricia North America

Holden Comprehensive Cancer Center at University of Iowa

Sudershan K Bhatia, MD, MPH, PhDPrincipal Investigator

Heather Brown, RN, BAN, OCNPh: (319) 384-7912
  Email: heather-brown@uiowa.edu

Trial Sites

U.S.A.
Iowa
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 Heather Brown, RN, BAN, OCN Ph: 319-384-7912
  Email: heather-brown@uiowa.edu
 Sandy Vollstedt, RN, BSN Ph: (319) 353 7143
  Email: sandy-vollstedt@uiowa.edu
 Sudershan k Bhatia, MD, MPH, PhDPrincipal Investigator
 Daniel James BergPrincipal Investigator
 John Michael BuattiPrincipal Investigator
 Douglas Spitz, PhDPrincipal Investigator
 Bryan Allen, MD, PhDSub-Investigator
 Melissa Fath, PhDSub-Investigator
 William Sivitz, MDSub-Investigator
 James R HoweSub-Investigator
 Hisakazu Hoshi, MDSub-Investigator
 Joseph J Cullen, MDSub-Investigator
 Robert J Robinson, MDSub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01419483
ClinicalTrials.gov processed this data on September 18, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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