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TerminatedNCT01419483KETOPANUpdated Jan 8, 2018

Ketogenic Diet With Concurrent Chemoradiation for Pancreatic Cancer

An interventional study of Ketogenic diet in Pancreatic Neoplasms, sponsored by University of Iowa. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-08.

Sponsored by University of Iowa · Not applicable, Interventional, and Treatment

Why this study was terminated
poor accrual
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Pancreatic Neoplasms

Keywords

  • Pancreatic neoplasms
  • Pancreatic cancer
  • Ketogenic Diet
  • radiotherapy
  • gemcitabine
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 5 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

University of Iowa is the lead sponsor of 276 studies on the registry; 35 are open to participants now.

Of its 44 completed or terminated interventional studies of FDA-regulated products, 39 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Ketogenic diet

    Diet designed to maintain elevated ketone levels during therapy

    Dietary Supplement: Ketogenic diet

Interventions

  • Dietary supplementKetogenic diet

    A ketogenic diet matching the fat to carbohydrate + proteins in Keto-Cal(R) 4:1 by Nutricia North America.

06

What researchers measure

Primary outcomes

  1. Frequency of Adverse Events (Safety)

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

    Time frame: Weekly for 8 weeks

Secondary outcomes

  1. Ketone levels

    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.

    Time frame: Daily during treatment for 6 weeks

  2. Blood glucose levels

    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.

    Time frame: Daily during treatment for 6 weeks

  3. Oxidative stress parameters

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

    Time frame: Weeks 1, 2, 3, 4, 5, and 6 of treatment and at 1 month follow-up

  4. Progression Free Survival (months)

    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.

    Time frame: Every 12 months for 60 months

07

Study locations

1 site
  • Holden Comprehensive Cancer Center
    Iowa City, Iowa 52242, United States
08

References and documents

Publications

  • Zahra A, Fath MA, Opat E, Mapuskar KA, Bhatia SK, Ma DC, Rodman SN III, Snyders TP, Chenard CA, Eichenberger-Gilmore JM, Bodeker KL, Ahmann L, Smith BJ, Vollstedt SA, Brown HA, Hejleh TA, Clamon GH, Berg DJ, Szweda LI, Spitz DR, Buatti JM, Allen BG. Consuming a Ketogenic Diet while Receiving Radiation and Chemotherapy for Locally Advanced Lung Cancer and Pancreatic Cancer: The University of Iowa Experience of Two Phase 1 Clinical Trials. Radiat Res. 2017 Jun;187(6):743-754. doi: 10.1667/RR14668.1. Epub 2017 Apr 24. PubMed 28437190 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01419483
Lead sponsor
University of Iowa
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI), Nutricia North America
Responsible party
Bryan Allen (Assistant Professor, University of Iowa) — Principal investigator
First posted
Aug 18, 2011
Start date
Jul 2011
Primary completion
Jul 2017
Completion
Jul 2017
Last update
Jan 8, 2018

Study contacts

Bryan G. Allen, MD, PhD
principal investigator · The Department of Radiation Oncology, The University of Iowa

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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