Ketogenic Diet Phase 1 for Head & Neck Cancer
|ClinicalTrials.gov Identifier: NCT01975766|
Recruitment Status : Terminated (Poor accrual)
First Posted : November 5, 2013
Last Update Posted : April 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Neoplasms||Dietary Supplement: Ketogenic diet Device: External beam radiation therapy||Not Applicable|
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.
- 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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of a Ketogenic Diet With Concurrent Chemoradiation for Head and Neck Cancer|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||July 11, 2017|
Experimental: Ketogenic diet
Ketogenic diet designed to sustain ketone levels through treatment.
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
- Frequency of adverse events (safety) [ Time Frame: weekly for 5 weeks ]Categorize and quantify adverse events in subjects implementing a ketogenic diet while undergoing definitive chemoradiation therapy.
- Ketone levels [ Time Frame: Daily during treatment for 5 weeks ]Quantify blood ketone levels via both finger-stick prior to daily radiation therapy and weekly lab analysis while on a ketogenic diet. Radiation is administered Monday through Friday only.
- Blood glucose levels [ Time Frame: daily during treatment for 5 weeks ]Quantify blood glucose levels via finger-stick prior to daily radiation therapy while on a ketogenic diet. Radiation therapy is administered Monday through Friday only.
- Oxidative stress parameters [ Time Frame: Weeks 1, 2, 3, 4, and 5 of treatment and at 1 month follow-up ]Determine oxidative stress parameters in plasma and urine samples during the course of treatment.
- Progression Free Survival (months) [ Time Frame: Every 12 months for 60 months ]From date of treatment until the first date of documented progression or date of death, whichever comes first, assessed no less than every 12 months for the first 60 months post-therapy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975766
|United States, Iowa|
|Holden Comprehensive Cancer Center|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Bryan G. Allen, MD, PhD||The University of Iowa|