Ketogenic Diet With Chemoradiation for Lung Cancer (KETOLUNG)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01419587|
Recruitment Status : Terminated (Poor accrual and compliance)
First Posted : August 18, 2011
Last Update Posted : January 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Dietary Supplement: Ketogenic diet||Not Applicable|
Standard treatment for lung cancer includes chemotherapy concurrent with radiation therapy (chemoradiation).
This study is a phase I trial to determine the safety of dietary manipulation during chemoradiation for lung 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 :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of a Ketogenic Diet With Concurrent Chemoradiation for Non-small Cell Lung Cancer|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||June 30, 2017|
|Actual Study Completion Date :||July 11, 2017|
Experimental: Ketogenic diet
Diet formulated to maintain elevated ketones during therapy
Dietary Supplement: Ketogenic diet
A ketogenic diet matching the fat to carbohydrate + proteins in Keto-Cal(R) 4:1 by Nutricia North America.
- Frequency of Adverse Events (Safety) [ Time Frame: Weekly for 8 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 6 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 6 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, 5, and 6 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419587
|United States, Iowa|
|Holden Comprehensive Cancer Center|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Bryan G. Allen, MD, PhD||The Department of Radiation Oncology, The University of Iowa|