Ketogenic Diet With Chemoradiation for Lung Cancer (KETOLUNG)

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.