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Clinical Trials (PDQ®)

Clinical Trials (PDQ®)

Ketogenic Diet With Chemoradiation for Lung Cancer (KETOLUNG)

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IBiomarker/Laboratory analysis, TreatmentActive18 and overNCI, Other201102773
1R21CA161182, NCT01419587

Trial Description

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 lung cancer patients.

Further Study Information

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 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Holden Comprehensive Cancer Center at University of Iowa

National Cancer Institute

National Cancer Institute

Holden Comprehensive Cancer Center at University of Iowa

Nutricia North America

Sudershan K. Bhatia, MD, MPH, PhDPrincipal Investigator

Heather Brown, RN, BAN, OCNPh: (319) 384-7912
  Email: heather-brown@uiowa.edu

Trial Sites

U.S.A.
Iowa
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 Heather Brown, RN, BAN, OCN Ph: 319-384-7912
  Email: heather-brown@uiowa.edu
 Sandy Vollstedt, RN, BSN Ph: (319) 353 7143
  Email: sandy-vollstedt@uiowa.edu
 Sudershan K Bhatia, MD, MPH, PhDPrincipal Investigator
 Daniel James BergPrincipal Investigator
 John Michael BuattiPrincipal Investigator
 Douglas Spitz, PhDPrincipal Investigator
 Bryan Allen, MD, PhDSub-Investigator
 Melissa Fath, PhDSub-Investigator
 William Sivitz, MDSub-Investigator
 Mark Iannettoni, MDSub-Investigator
 Kal Parekh, MDSub-Investigator
 Robert J Robinson, MDSub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01419587
ClinicalTrials.gov processed this data on October 19, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.