Ketogenic Diet in Advanced Cancer

This study is currently recruiting participants.
Verified October 2012 by VA Pittsburgh Healthcare System
Sponsor:
Information provided by (Responsible Party):
Jocelyn Tan, VA Pittsburgh Healthcare System
ClinicalTrials.gov Identifier:
NCT01716468
First received: September 18, 2012
Last updated: October 26, 2012
Last verified: October 2012
  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
Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Low-Carbohydrate Diet for Advanced or Metastatic Cancer

Resource links provided by NLM:


Further study details as provided by VA Pittsburgh Healthcare System:

Estimated Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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).

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

Contacts
Contact: Jocelyn Tan, MD 412-360-6178 jocelyn.tan@va.gov
Contact: Jennifer Carrick, RN, MS, CCRC 412-360-3653 jennifer.carrick@va.gov

Locations
United States, Pennsylvania
VA Pittsburgh Healthcare System Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Jocelyn Tan, MD    412-360-6178    jocelyn.tan@va.gov   
Contact: Jennifer Carrick, RN, MS, CCRC    412-360-3653    jennifer.carrick@va.gov   
Principal Investigator: Jocelyn Tan, MD         
Sponsors and Collaborators
VA Pittsburgh Healthcare System
Investigators
Principal Investigator: Jocelyn Tan, MD VA Pittsburgh Healthcare System
  More Information

No publications provided

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
Last Updated: October 26, 2012
Health Authority: United States: Federal Government

Keywords provided by VA Pittsburgh Healthcare System:
Ketogenic Diet, Advanced Cancer, Neoplasm

ClinicalTrials.gov processed this record on April 17, 2014