Clinical trial · Interventional
Ketogenic Diet in Advanced Cancer
A Low-Carbohydrate Diet for Advanced or Metastatic Cancer
NCT01716468CI-TRIAL-00022060completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety and tolerability of a modified low carbohydrate diet, determine if quality of life is improved and to determine if the diet has any effect on tumor growth (size or spread) and or to determine if there is any effect on progression free survival (PFS) and overall survival (OS) of subjects enrolled in the study.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ketogenic Diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Advanced or metastatic cancer
- description
- Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).All participants will be assigned to a ketogenic diet. There are no randomization to other separate arms since this is a safety and feasibility study.
- interventionNames
- Other: Ketogenic Diet
Primary outcomes (1)
- measure
- To Determine the Safety and Tolerability of a Modified Low Carbohydrate Diet in People With Advanced Cancer Across Different Tumor Types.
- timeFrame
- 16 weeks
- description
- Recent studies involving human patients with brain cancer showed tolerability of the Ketogenic diet over a period as long as 19 months with minimal side effects. It is hypothesized that the effect this diet will have on overall weight loss, hyperlipidemia, and blood glucose levels will be minimal and tolerable even by cancer patients over a prolonged period of time, up to 12 months or possibly longer. Serum fasting glucose, cholesterol, total, LDL, HDL and triglycerides, serum ketones in mg/dl units , weight in lbs. will be measured at designated time points. Number of patients actually tolerating the diet for at least 4 weeks or more will be recorded.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Subjects must meet all of the following criteria to be eligible for the study: * 18 years of age or older. * English speaking and written informed consent obtained. * Patients presenting to the VAPHS Oncology inpatient or outpatient clinic with cancer of advanced or metastatic stage. * Must have measurable disease at least 1 cm in greatest diameter on CT or MRI scanning. If a new FDG avid satellite lesions are noted this will be counted as disease progression. The minimum size is 1 cm. The tumor will be measured at the longest diameter. Either the primary tumor or metastatic tumor, either may be used. In absence of primary tumor, we usually measure the next largest metastatic lesion. The tumor will be chose by using RECIST criteria measure (at the screening visit) tumors, then using the 4 response criteria, CR complete response= disappearance of all target lesions, PR= 30% decrease in the sum of the longest diameter of target lesions, PD progressive disease= 20% increase in the sum of the longest diameter of target lesions, and SD stable disease= small changes that don't meet the above criteria * Patients must have solid, advanced or metastatic tumors, and have failed to respond to chemotherapy or on chemotherapy holiday. * Tumors must be PET positive in primary or metastatic site. * Patients must not be actively receiving chemotherapy after holiday or have refused or failed one or more prior chemotherapy or radiotherapy treatment. * Subjects may be enrolled in any other studies as long as they are not under an active form of chemotherapy or radiotherapy intervention. * No subjects will be excluded based on their race, religion, ethnicity, and gender or HIV status, as applicable. Exclusion: * Prisoners or subjects who are involuntarily incarcerated. * Secondary brain metastases. * History of Gout. * AST or ATL \> 1.5 X ULN. * Creatinine \> 2.0. * Hematologic malignancies * BMI \< 22. * History of kidney disease or kidney stones. * Receiving chemotherapy including biologics. * Recent AMI/TIA or stroke within one month of study entry. * ECOG performance status of 3 or worse.
References
Publications (1)
- DERIVEDTan-Shalaby JL, Carrick J, Edinger K, Genovese D, Liman AD, Passero VA, Shah RB. Modified Atkins diet in advanced malignancies - final results of a safety and feasibility trial within the Veterans Affairs Pittsburgh Healthcare System. Nutr Metab (Lond). 2016 Aug 12;13:52. doi: 10.1186/s12986-016-0113-y. eCollection 2016. PMID 27525031