Spots Global Cancer Trial Database for Ketogenic Diet Phase 1 for Head & Neck Cancer

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Trial Identification

Brief Title: Ketogenic Diet Phase 1 for Head & Neck Cancer

Official Title: A Phase I Trial of a Ketogenic Diet With Concurrent Chemoradiation for Head and Neck Cancer

Study ID: NCT01975766

Conditions

Head and Neck Neoplasms

Interventions

Ketogenic diet

External beam radiation therapy

Study Description

Brief 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.

Detailed Description: 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