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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 Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Cancer
Intervention Other: Ketogenic Diet
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Advanced or Metastatic Cancer
Hide Arm/Group 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).
Period Title: Overall Study
Started 17
Completed 11
Not Completed 6
Arm/Group Title Advanced or Metastatic Cancer
Hide Arm/Group 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).
Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
  52.9%
>=65 years
8
  47.1%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 17 participants
65
(44 to 90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
0
   0.0%
Male
17
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants
17
1.Primary Outcome
Title To Determine the Safety and Tolerability of a Modified Low Carbohydrate Diet in People With Advanced Cancer Across Different Tumor Types.
Hide 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.
Time Frame 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Solid cancers or blood cancers with measurable components in advanced or metastatic stages.
Arm/Group Title Advanced or Metastatic Cancer
Hide Arm/Group 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).
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
11
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Advanced or Metastatic Cancer
Hide Arm/Group 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-Cause Mortality
Advanced or Metastatic Cancer
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Advanced or Metastatic Cancer
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Advanced or Metastatic Cancer
Affected / at Risk (%)
Total   7/11 (63.64%) 
General disorders   
Grade 1 Weight Loss  6/11 (54.55%) 
Grade 2 weight Loss  1/11 (9.09%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jocelyn Tan, MD
Organization: VA Pittsburgh Healthcare System
Phone: 412-360-6178
Responsible Party: Jocelyn Tan, VA Pittsburgh Healthcare System
ClinicalTrials.gov Identifier: NCT01716468     History of Changes
Other Study ID Numbers: PRO00000367
First Submitted: September 18, 2012
First Posted: October 29, 2012
Results First Submitted: February 9, 2016
Results First Posted: May 9, 2016
Last Update Posted: May 9, 2016