ketogenic diet phase 1 for head & neck cancer

Conditions: Head and Neck Neoplasms

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 patients.

standard treatment for head \& neck cancer often includes chemotherapy concurrent with radiation therapy (chemoradiation). this study is a phase i trial to determine the safety of dietary manipulation during chemoradiation for head \& neck 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 squamous cell carcinoma of the oropharynx, larynx or hypopharynx. hpv status will not be assessed for eligibility; while hpv status may affect response to therapy, efficacy is not an outcome measure for this phase i study. * candidate for primary chemoradiation as decided by an interdisciplinary team including otolaryngology, medical oncology, and radiation oncology. * cancer should be staged via ajcc as stage ii, iii or iva. * age ≥ 18 years * ecog performance status 0-2 (karnofsky \> 50%, see appendix a). * 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 \< 8% * ast(sgot) \< 2 x institutional upper limit of normal * creatinine \< 1.5 x institutional upper limit of normal or calculated 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 neck and/or upper thoracic radiotherapy that would cause an overlap of treatment fields. * prior therapy to the head and neck, with the intent to treat, the current diagnosis of head \& neck cancer. * known / established g6pd (glucose-6-phosphate dehydrogenase) deficiency. * chronic system corticosteroids for any reason (inhaled corticosteroids are allowed). pre-medication for chemotherapy is acceptable. * 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.

Keywords: carcinoma, squamous cell of head and neck head and neck cancer ketogenic diet radiotherapy cisplatin