Ketogenic Diet With Concurrent Chemoradiation for Pancreatic Cancer (KETOPAN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Iowa
Sponsor:
Collaborators:
Nutricia North America
Holden Comprehensive Cancer Center
Information provided by (Responsible Party):
Sudershan Bhatia, University of Iowa
ClinicalTrials.gov Identifier:
NCT01419483
First received: July 28, 2011
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Pancreatic Neoplasms
Dietary Supplement: Ketogenic diet
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Trial of a Ketogenic Diet With Concurrent Chemoradiation for Pancreatic Cancer.

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Frequency of Adverse Events (Safety) [ Time Frame: Weekly for 8 weeks ] [ Designated as safety issue: Yes ]
    Categorize and quantify adverse events in subjects implementing a ketogenic diet while undergoing definitive chemoradiation therapy.


Secondary Outcome Measures:
  • Ketone levels [ Time Frame: Daily during treatment for 6 weeks ] [ Designated as safety issue: No ]
    Quantify blood ketone levels via both finger-stick prior to daily radiation therapy and weekly lab analysis while on a ketogenic diet. Radiation is administered Monday through Friday only.

  • Blood glucose levels [ Time Frame: Daily during treatment for 6 weeks ] [ Designated as safety issue: Yes ]
    Quantify blood glucose levels via finger-stick prior to daily radiation therapy while on a ketogenic diet. Radiation therapy is administered Monday through Friday only.

  • Oxidative stress parameters [ Time Frame: Weeks 1, 2, 3, 4, 5, and 6 of treatment and at 1 month follow-up ] [ Designated as safety issue: No ]
    Determine oxidative stress parameters in plasma and urine samples during the course of treatment.

  • Progression Free Survival (months) [ Time Frame: Every 12 months for 60 months ] [ Designated as safety issue: Yes ]
    From date of treatment until the first date of documented progression or date of death, whichever comes first, assessed no less than every 12 months for the first 60 months post-therapy.


Estimated Enrollment: 10
Study Start Date: July 2011
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Ketogenic diet
    A ketogenic diet matching the fat to carbohydrate + proteins in Keto-Cal(R) 4:1 by Nutricia North America.
Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01419483

Contacts
Contact: Heather Brown, RN, BAN, OCN (319) 384-7912 heather-brown@uiowa.edu
Contact: Sandy Vollstedt, RN, BSN (319) 353 7143 sandy-vollstedt@uiowa.edu

Locations
United States, Iowa
Holden Comprehensive Cancer Center Recruiting
Iowa City, Iowa, United States, 52242
Contact: Heather Brown, RN, BAN, OCN    319-384-7912    heather-brown@uiowa.edu   
Contact: Sandy Vollstedt, RN, BSN    (319) 353 7143    sandy-vollstedt@uiowa.edu   
Principal Investigator: Sudershan k Bhatia, MD, MPH, PhD         
Principal Investigator: Daniel Berg, MD         
Principal Investigator: John M Buatti, MD         
Principal Investigator: Douglas Spitz, PhD         
Sub-Investigator: Bryan Allen, MD, PhD         
Sub-Investigator: Melissa Fath, PhD         
Sub-Investigator: William Sivitz, MD         
Sub-Investigator: James Howe, MD         
Sub-Investigator: Hisakazu Hoshi, MD         
Sub-Investigator: Joseph J Cullen, MD         
Sub-Investigator: Robert J Robinson, MD         
Sponsors and Collaborators
University of Iowa
Nutricia North America
Holden Comprehensive Cancer Center
Investigators
Principal Investigator: Sudershan K Bhatia, MD, MPH, PhD The Department of Radiation Oncology, The University of Iowa
  More Information

Additional Information:
No publications provided

Responsible Party: Sudershan Bhatia, Clinical Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01419483     History of Changes
Other Study ID Numbers: 201102772, 1R21CA161182
Study First Received: July 28, 2011
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Iowa:
Pancreatic neoplasms
Pancreatic cancer
Ketogenic Diet
radiotherapy
gemcitabine

Additional relevant MeSH terms:
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 21, 2014