Clinical trial · Interventional
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
NCT01419587CI-TRIAL-00031061terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor accrual and compliance
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ketogenic diet | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ketogenic diet
- description
- Diet formulated to maintain elevated ketones during therapy
- interventionNames
- Dietary Supplement: Ketogenic diet
Primary outcomes (1)
- measure
- Frequency of Adverse Events (Safety)
- timeFrame
- Weekly for 8 weeks
- description
- Categorize and quantify adverse events in subjects implementing a ketogenic diet while undergoing definitive chemoradiation therapy.
Secondary outcomes (4)
- measure
- Ketone levels
- timeFrame
- Daily during treatment for 6 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTZahra A, Fath MA, Opat E, Mapuskar KA, Bhatia SK, Ma DC, Rodman SN III, Snyders TP, Chenard CA, Eichenberger-Gilmore JM, Bodeker KL, Ahmann L, Smith BJ, Vollstedt SA, Brown HA, Hejleh TA, Clamon GH, Berg DJ, Szweda LI, Spitz DR, Buatti JM, Allen BG. Consuming a Ketogenic Diet while Receiving Radiation and Chemotherapy for Locally Advanced Lung Cancer and Pancreatic Cancer: The University of Iowa Experience of Two Phase 1 Clinical Trials. Radiat Res. 2017 Jun;187(6):743-754. doi: 10.1667/RR14668.1. Epub 2017 Apr 24. PMID 28437190