NCT01419483

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 18, 2011

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

January 8, 2018

Status Verified

January 1, 2018

Enrollment Period

6 years

First QC Date

July 28, 2011

Last Update Submit

January 4, 2018

Conditions

Pancreatic Neoplasms

Keywords

Pancreatic neoplasmsPancreatic cancerKetogenic Dietradiotherapygemcitabine

Outcome Measures

Primary Outcomes (1)

  • Frequency of Adverse Events (Safety)

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

    Weekly for 8 weeks

Secondary Outcomes (4)

  • Ketone levels

    Daily during treatment for 6 weeks

  • Blood glucose levels

    Daily during treatment for 6 weeks

  • Oxidative stress parameters

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

  • Progression Free Survival (months)

    Every 12 months for 60 months

Study Arms (1)

Ketogenic diet

EXPERIMENTAL

Diet designed to maintain elevated ketone levels during therapy

Dietary Supplement: Ketogenic diet

Interventions

Ketogenic dietDIETARY_SUPPLEMENT

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

Ketogenic diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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%).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

  • 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.

    PMID: 28437190RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Bryan G. Allen, MD, PhD

    The Department of Radiation Oncology, The University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 28, 2011

First Posted

August 18, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

January 8, 2018

Record last verified: 2018-01

Locations

US(1)