Low-Carbohydrate Normocaloric Diet in Patients With Head and Neck Carcinoma (HNC)

PRIMARY OBJECTIVES:

I. Assess the impact of a low-carbohydrate normocaloric diet on transporter of the outer mitochondrial membrane subunit 20 (TOMM20) expression by immunohistochemistry (IHC) in carcinoma cells and the impact of a low-carbohydrate normocaloric diet on monocarboxylate transporter 4 (MCT4) expression in fibroblasts.

SECONDARY OBJECTIVES:

I. Assess the feasibility of a low-carbohydrate normocaloric diet treatment in head and neck carcinoma (HNC) patients.

II. Assess the effect of a low-carbohydrate normocaloric diet on the serum levels of insulin, and insulin growth factor (IGF)-1 and -2.

III. Assess the potential impact of a low-carbohydrate normocaloric diet on the following: disease-free survival, distant metastases-free survival, overall survival.

IV. To evaluate the utility of cancer-derived exosomes to serve as prognostic biomarkers for real-time monitoring of therapeutic efficacy and identifying early recurrence using longitudinal samples from cancer patients undergoing treatment.

OUTLINE:

Patients follow a normocaloric, low-carbohydrate diet for 10-28 days (from the time of cancer diagnosis to definitive surgical treatment).

After completion of study, patients are followed up at 1 month, 3 months, and then every 3 months for 24 months.

Inclusion criteria

• Patients with a diagnosis of head and neck cancer biopsy proven, and who have a scheduled appointment for definitive resection of the tumor at TJUH are eligible to participate.
• Subjects must be ≥ 18 and ≤ 70 years of age.
• KPS > 70
• Expected survival > 6 months.
• Adequate organ functions (hematological, hepatic, renal function).
• Absolute neutrophil count > 1.5 x 109/L, platelet count > 100 x 109/L, hemoglobin > 9 g/L, total bilirubin < 1.25 x the institutional upper limit of normal [ULN], albumin > 2.5 g/dL, aspartate aminotransferase < 45 IU/dL, alanine aminotransferase < 40 IU/dL, alkaline phosphatase ≤ 190 IU/dL and serum creatinine < 1.3 mg/dL and creatinine clearance > 50 mL/min.
• Serum potassium and magnesium, and corrected serum calcium within the institution's normal reference range.
• Ability to provide written informed consent obtained prior to participation in the study.
• Women of childbearing potential (WOCBP) must be willing to use an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized.
• Patients' availability to check their weight twice per week, during the study duration.

Exclusion criteria

• Diabetic patients are eligible but will be excluded if they are taking metformin, insulin or sulfonilureas.
• Patients with plasma alanine aminotransferase greater than 40 IU/dL.
• Patients with plasma aspartate aminotransferase greater than 45 IU/dL.
• Patients with plasma creatinine level greater than 1.3 mg/dL.
• Patients with plasma alkaline phosphatase greater than 190 IU/dL.
• Patients with plasma bicarbonate less than 22 mEq/L or history of lactic or any other metabolic acidosis.
• Patients with history of congestive heart failure.
• Patients with myocardial ischemia or peripheral muscle ischemia.
• Patients with sepsis or severe infection.
• Patients with history of lung disease currently requiring any pharmacologic or supplemental oxygen treatment.
• Patients scheduled for definitive HNC cancer surgical resection less than 10 days from enrollment or greater than five weeks from enrollment.
• Patients with history of hepatic dysfunction or hepatic disease.
• Patients with a history of excessive alcohol intake which is defined in accordance with CDC definitions as more than 1 drink per day for women and more than 2 drinks per day for men. This definition is referring to the amount consumed on any single day and is not intended as an average over several days. A standard drink is equal to 13.7 grams (0.6 ounces) of pure alcohol. Generally, this amount of pure alcohol is found in 12-ounces of beer, 8-ounces of malt liquor, 5-ounces of wine, 1.5-ounces or a "shot" of 80-proof distilled spirits or liquor (e.g., gin, rum, vodka, or whiskey).
• Patients with a lower BMI (BMI<18) will be excluded.
• Patients with history of known defects in fat metabolism (ie pyruvate carboxylase deficiency, prophyria, fatty acid oxidation defects, primary carnitine deficiencies, organic acidurias, hypoglicemia) will be excluded.
• Pregnancy, lactation or inability to use medically acceptable birth control if of childbearing potential.