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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


  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.
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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


  Other Adverse Events


  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