NCT01975766

Ketogenic Diet Phase 1 for Head & Neck Cancer

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Bryan Allen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Head and Neck Neoplasms

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ketogenic diet	A ketogenic diet matching the fat to carbohydrate + proteins in Keto-Cal(R) 4:1 by Nutricia North America.
DEVICE	External beam radiation therapy

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-11-01
• Completion: 2017-07-11
• First posted: 2013-11-05
• Last updated: 2018-06-26

Locations

1 site across 1 country: United States