Status:
TERMINATED
Atkins Diet and Prostate Cancer Clinical Trial
Lead Sponsor:
Duke University
Collaborating Sponsors:
VA Greater Los Angeles Healthcare System
Durham VA Medical Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This study will test the hypothesis that a low-carbohydrate Atkins diet will prevent or at least minimize the metabolic consequences of androgen deprivation therapy (ADT).
Detailed Description
Androgen deprivation therapy (ADT) is the standard treatment for advanced prostate cancer. While a very effective anti-cancer treatment, ADT is associated with significant toxicity including but not l...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the prostate
- Scheduled to initiate ADT with an anticipated duration of ≥ 6 months
- Overweight or obese (body mass index ≥ 25 kg/m2)
Exclusion
- Symptomatic metastatic disease
- Myocardial infarction within 6 months
- Treatment with medications known to affect insulin or glucose levels (i.e. insulin, oral hypoglycemics, prednisone, etc.)
- Patient consuming a low-carbohydrate diet
- Medical conditions or co-morbidities that preclude participation in the protocol
- Vegetarians
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00932672
Start Date
June 1 2009
End Date
October 1 2014
Last Update
December 7 2015
Active Locations (3)
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1
Greater Los Angeles VA Medical Center
Los Angeles, California, United States, 90073
2
University of California, Los Angeles
Los Angeles, California, United States, 90095
3
Duke University Medical Center
Durham, North Carolina, United States, 27710