Ketogenic Diet With Chemoradiation for Lung Cancer (KETOLUNG)

This study is currently recruiting participants.
Verified October 2013 by University of Iowa
Sponsor:
Collaborators:
Holden Comprehensive Cancer Center
Nutricia North America
Information provided by (Responsible Party):
Sudershan Bhatia, University of Iowa
ClinicalTrials.gov Identifier:
NCT01419587
First received: July 29, 2011
Last updated: October 18, 2013
Last verified: October 2013
  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 lung cancer patients.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
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 Non-small Cell Lung 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 2016
Estimated Primary Completion Date: July 2014 (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 lung 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 lung 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:

  • Histologically or cytologically documented NSCLC.
  • Candidate for primary chemoradiation as decided by both medical and radiation oncology.
  • Cancer should be staged via AJCC as IIIA or IIIB.
  • Stage IV patients are considered provided they have a single non-CNS metastasis (that is amenable to treatment with radiation therapy).
  • 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 < 1.5 mg/dl
  • Hgb A1C < or = to 8%
  • AST(SGOT) < or = to 2 X institutional upper limit of normal
  • 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:

  • Life expectancy of 3 or less months.
  • Prior thoracic radiotherapy.
  • Prior therapy, with the intent to treat, the current diagnosis of lung cancer.
  • Known G6PD (glucose-6-phosphate dehydrogenase) deficiency.
  • Systemic corticosteroids for any reason (inhaled corticosteroids are allowed).
  • 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 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, or psychiatric illness/social situations 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419587

Contacts
Contact: Jane Hershberger, RN, BSN (319) 384-7912 jane-hershberger@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: Jane Hershberger, RN, BSN    319-384-7912    jane-hershberger@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 J. 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: Ahmad Wehbe, MD         
Sub-Investigator: William Sivitz, MD         
Sub-Investigator: Margaret Bayless, CDE CCRC RN         
Sub-Investigator: Cathy Chenard, MS, RD, LD         
Sub-Investigator: Mark Iannettoni, MD         
Sub-Investigator: Kal Parekh, MD         
Sub-Investigator: Robert J Robinson, MD         
Sponsors and Collaborators
University of Iowa
Holden Comprehensive Cancer Center
Nutricia North America
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: NCT01419587     History of Changes
Other Study ID Numbers: 201102773, 1R21CA161182
Study First Received: July 29, 2011
Last Updated: October 18, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Iowa:
Carcinoma, Non-Small-Cell Lung
Non small cell lung cancer
NSCLC
Ketogenic Diet
radiotherapy
paclitaxel
carboplatin

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014