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Ketogenic Diet in Advanced Cancer

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ClinicalTrials.gov Identifier: NCT01716468
Recruitment Status : Completed
First Posted : October 29, 2012
Results First Posted : May 9, 2016
Last Update Posted : May 9, 2016
Sponsor:
Information provided by (Responsible Party):
Jocelyn Tan, VA Pittsburgh Healthcare System

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Cancer Other: Ketogenic Diet Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Low-Carbohydrate Diet for Advanced or Metastatic Cancer
Study Start Date : October 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : December 2015
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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 Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jocelyn Tan, Attending Physician-Hematology/Oncology, VA Pittsburgh Healthcare System
ClinicalTrials.gov Identifier: NCT01716468     History of Changes
Other Study ID Numbers: PRO00000367
First Posted: October 29, 2012    Key Record Dates
Results First Posted: May 9, 2016
Last Update Posted: May 9, 2016
Last Verified: April 2016

Keywords provided by Jocelyn Tan, VA Pittsburgh Healthcare System:
Ketogenic Diet, Advanced Cancer, Neoplasm
Low carbohydrate