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Ketogenic Diet With Chemoradiation for Lung Cancer (KETOLUNG)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 6, 2014
Last verified: June 2014

July 29, 2011
June 6, 2014
July 2011
July 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01419587 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Ketogenic Diet With Chemoradiation for Lung Cancer (KETOLUNG)
A Phase I Trial of a Ketogenic Diet With Concurrent Chemoradiation for Non-small Cell Lung Cancer

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.

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
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
Dietary Supplement: Ketogenic diet
A ketogenic diet matching the fat to carbohydrate + proteins in Keto-Cal(R) 4:1 by Nutricia North America.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
July 2017
July 2015   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact: Heather Brown, RN, BAN, OCN (319) 384-7912 heather-brown@uiowa.edu
Contact: Sandy Vollstedt, RN, BSN, OCN (319) 353 7143 sandy-vollstedt@uiowa.edu
United States
 
NCT01419587
201102773, 1R21CA161182
Yes
Sudershan Bhatia, University of Iowa
University of Iowa
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
  • Holden Comprehensive Cancer Center
  • Nutricia North America
Principal Investigator: Sudershan K. Bhatia, MD, MPH, PhD The Department of Radiation Oncology, The University of Iowa
University of Iowa
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP