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Ketogenic Diet in Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition: Cancer
Intervention: Other: Ketogenic Diet

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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).

Participant Flow:   Overall Study
    Advanced or Metastatic Cancer
STARTED   17 
COMPLETED   11 
NOT COMPLETED   6 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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).

Baseline Measures
   Advanced or Metastatic Cancer 
Overall Participants Analyzed 
[Units: Participants]
 17 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   9 
>=65 years   8 
Age 
[Units: Years]
Mean (Full Range)
 65 
 (44 to 90) 
Gender 
[Units: Participants]
 
Female   0 
Male   17 
Region of Enrollment 
[Units: Participants]
 
United States   17 


  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
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).

Serious Adverse Events
    Advanced or Metastatic Cancer
Total, Serious Adverse Events   
# participants affected / at risk   0/11 (0.00%) 




  Other Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
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).

Other Adverse Events
    Advanced or Metastatic Cancer
Total, Other (not including serious) Adverse Events   
# participants affected / at risk   7/11 (63.64%) 
General disorders   
Grade 1 Weight Loss   
# participants affected / at risk   6/11 (54.55%) 
Grade 2 weight Loss   
# participants affected / at risk   1/11 (9.09%) 



  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: Jocelyn.Tan@va.gov


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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