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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01419587.
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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.
OUTLINE:
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.
Lead OrganizationUniversity of Iowa/Holden Comprehensive Cancer Center
Principal InvestigatorSudershan K Bhatia
