Status:
TERMINATED
Ketogenic Diet With Chemoradiation for Lung Cancer (KETOLUNG)
Lead Sponsor:
University of Iowa
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
NA
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 lung cancer patients.
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 chemo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2017
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01419587
Start Date
July 1 2011
End Date
July 11 2017
Last Update
January 8 2018
Active Locations (1)
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1
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242