Ketogenic Diet in Treating Patients With Stage III-IV Non-Small Cell Lung Cancer Undergoing Chemoradiation

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IBiomarker/Laboratory analysis, Treatment18 and over201102773
NCI-2012-00327, 02110110, NCT01419587

Trial Description



The purpose of this research study is to determine the effects, good and bad, that using a special diet has on patients during chemotherapy and radiation therapy for lung cancer. If the diet is tolerated, we will open studies to see if using the diet improves the survival of lung cancer patients. Ketogenic diet has a very low level of carbohydrates (sugars). Most calories in the diet come from protein and fat.

Further Study Information


I. Determine the safety of administering a ketogenic diet during concurrent carboplatin-paclitaxel-radiation therapy for the definitive treatment of locally advanced non-small cell lung cancer.


I. Quantify blood ketone levels via finger-stick prior to daily radiation therapy and clinical analysis.

II. Quantify blood glucose levels via finger-stick prior to daily radiation therapy.

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

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


Patients receive ketogenic diet daily beginning a minimum of 2 days prior to radiation therapy and continuing for at least 5 weeks. Patients receive paclitaxel intravenously (IV) over 60 minutes and carboplatin IV over 30 minutes once weekly for up to 7 weeks and undergo radiation therapy five times a week for approximately 6.5 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 3 months for 1 year.

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically documented non-small cell lung cancer (NSCLC)

Candidate for primary chemoradiation as decided by both medical and radiation oncology

Cancer should be staged via American Joint Committee on Cancer (AJCC) as IIIA or IIIB

Stage IV patients are considered provided they have a single non-central nervous system (CNS) metastasis (that is amenable to treatment with radiation therapy)

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Karnofsky > 50%

Hypertensive medication should be initiated or increased for optimal blood pressure control according to standard public health guidelines prior to starting the ketogenic diet

Leukocytes >= 3,000/mm^3

Absolute neutrophil count >= 1,500/mm^3

Platelets >= 100,000/mm^3

Total bilirubin < 1.5 mg/dl

Hemoglobin (Hgb) A1C =< 8%

Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2 X institutional upper limit of normal

Creatinine < 1.5 X institutional upper limit of normal OR creatinine clearance >= 60 mL/min/1.73 m^2 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

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

University of Iowa/Holden Comprehensive Cancer Center

  • National Cancer Institute
Sudershan K. Bhatia, Principal Investigator

Trial Sites


Iowa City

University of Iowa/Holden Comprehensive Cancer Center

Sudershan K. Bhatia
Ph: 319-356-7609

Sudershan K. Bhatia
Principal Investigator

Link to the current record.
NLM Identifer NCT01419587

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the record via the link above for more information about participating sites.