- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01419587
Ketogenic Diet With Chemoradiation for Lung Cancer (KETOLUNG)
A Phase I Trial of a Ketogenic Diet With Concurrent Chemoradiation for Non-small Cell Lung Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- Holden Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically or cytologically documented NSCLC.
- Candidate for primary chemoradiation as decided by both medical and radiation oncology.
- Cancer should be staged via AJCC as IIIA or IIIB.
- Stage IV patients are considered provided they have a single non-CNS metastasis (that is amenable to treatment with radiation therapy).
- Age ≥ 18 years
- ECOG performance status 0-2 (Karnofsky > 50%, see Appendix A).
- Hypertensive medication should be initiated or increased for optimal blood pressure control according to standard public health guidelines prior to starting the ketogenic diet.
- 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 < or = to 8%
- AST(SGOT) < or = to 2 X institutional upper limit of normal
- creatinine < 1.5 X institutional upper limit of normal OR 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 thoracic radiotherapy.
- Prior therapy, with the intent to treat, the current diagnosis of lung cancer.
- Known G6PD (glucose-6-phosphate dehydrogenase) deficiency.
- Systemic corticosteroids for any reason (inhaled corticosteroids are allowed).
- 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.
Female and male patients of all ethnic groups will be eligible for treatment in these protocols.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ketogenic diet
Diet formulated to maintain elevated ketones during therapy
|
A ketogenic diet matching the fat to carbohydrate + proteins in Keto-Cal(R) 4:1 by Nutricia North America.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Weekly for 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Daily during treatment for 6 weeks
|
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.
|
Daily during treatment for 6 weeks
|
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.
|
Weeks 1, 2, 3, 4, 5, and 6 of treatment and at 1 month follow-up
|
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.
|
Every 12 months for 60 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bryan G. Allen, MD, PhD, The Department of Radiation Oncology, The University of Iowa
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201102773
- 1R21CA161182 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carcinoma, Non-Small-Cell Lung
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Bristol-Myers SquibbCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung Carcinoma | Non-Squamous Non-Small...United States
-
National Cancer Institute (NCI)CompletedStage IIIA Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Recurrent Lung Non-Small Cell Carcinoma | Stage IIIB Lung Non-Small Cell Cancer AJCC v7 | Stage IA...United States
-
National Cancer Institute (NCI)Active, not recruitingLung Non-Squamous Non-Small Cell Carcinoma | Stage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage II Lung Non-Small Cell Cancer AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7United States, Puerto Rico
-
M.D. Anderson Cancer CenterActive, not recruitingStage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage II Lung Non-Small Cell Cancer AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Stage I Lung Non-Small Cell Cancer AJCC v7 | Stage...United States
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
National Cancer Institute (NCI)Active, not recruitingStage IIIA Lung Non-Small Cell Cancer AJCC v7 | Advanced Lung Non-Squamous Non-Small Cell Carcinoma | Metastatic Lung Non-Squamous Non-Small Cell Carcinoma | Stage IIIB Lung Non-Small Cell Cancer AJCC v7 | Stage IV Lung Non-Small Cell Cancer AJCC v7 | Stage III Lung Non-Small Cell Cancer AJCC...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI); Society of Thoracic RadiologyActive, not recruitingStage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
National Cancer Institute (NCI)CompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
Clinical Trials on Ketogenic diet
-
Shriners Hospitals for ChildrenUniversity of HawaiiCompleted
-
University of PittsburghBaszucki Brain Research FundRecruitingBipolar DisorderUnited States
-
University of Roma La SapienzaCompleted
-
Kuopio University HospitalDeakin UniversityRecruitingPsychotic Disorders | Schizophrenia | Psychosis | Psychosis; AcuteFinland
-
Mid-Atlantic Epilepsy and Sleep Center, LLCUnknown
-
University of FloridaRecruitingSeizuresUnited States
-
Helse Nord-Trøndelag HFNorwegian University of Science and Technology; Vanderbilt University Medical... and other collaboratorsActive, not recruiting
-
University of Maryland, BaltimoreRecruiting
-
Ohio State UniversityRecruiting
-
University of PadovaUniversity of Palermo; Universidade Federal de GoiasCompleted