Ketogenic Diet in Advanced Cancer - Full Text View

Purpose

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.

Condition	Intervention
Cancer	Other: Ketogenic Diet


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	A Low-Carbohydrate Diet for Advanced or Metastatic Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by VA Pittsburgh Healthcare System:

Primary Outcome Measures:

To Determine the Safety and Tolerability of a Modified Low Carbohydrate Diet in People With Advanced Cancer Across Different Tumor Types. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
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.


Enrollment:	17
Study Start Date:	October 2012
Study Completion Date:	December 2015
Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Advanced or metastatic cancer 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.	Other: Ketogenic Diet modified ketogenic diet

Arms

Assigned Interventions

Advanced or metastatic cancer

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.

Other: Ketogenic Diet

modified ketogenic diet

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Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716468

Locations


United States, Pennsylvania
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15240

Sponsors and Collaborators

VA Pittsburgh Healthcare System

Investigators


Principal Investigator:	Jocelyn Tan, MD	VA Pittsburgh Healthcare System

More Information


Responsible Party:	Jocelyn Tan, Attending Physician-Hematology/Oncology, VA Pittsburgh Healthcare System
ClinicalTrials.gov Identifier:	NCT01716468 History of Changes
Other Study ID Numbers:	PRO00000367
Study First Received:	September 18, 2012
Results First Received:	February 9, 2016
Last Updated:	April 9, 2016
Health Authority:	United States: Federal Government

Keywords provided by VA Pittsburgh Healthcare System:


Ketogenic Diet, Advanced Cancer, Neoplasm Low carbohydrate

ClinicalTrials.gov processed this record on September 30, 2016