Clinical trial NCT00932672: Atkins Diet and Prostate Cancer Clinical Trial
Official title: Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men Initiating Androgen Deprivation Therapy For Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Atkins
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: VA Greater Los Angeles Healthcare System
name: Durham VA Medical Center
name: University of California, Los Angeles
name: Carolina Urologic Research Center
name: First Urology
First posted: 2009-07-03
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 limited to major metabolic disturbances including impaired glucose tolerance, insulin resistance, and weight gain. We hypothesize that limiting carbohydrates within the diet will prevent or at least minimize these consequences.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the prostate
2. Scheduled to initiate ADT with an anticipated duration of ≥ 6 months
3. Overweight or obese (body mass index ≥ 25 kg/m2)

Exclusion Criteria:

1. Symptomatic metastatic disease
2. Myocardial infarction within 6 months
3. Treatment with medications known to affect insulin or glucose levels (i.e. insulin, oral hypoglycemics, prednisone, etc.)
4. Patient consuming a low-carbohydrate diet
5. Medical conditions or co-morbidities that preclude participation in the protocol
6. Vegetarians

Primary outcomes:
measure: The primary end-point will be differences in insulin sensitivity between the arms
timeFrame: 6 months
Secondary outcomes:
measure: Measures will include other cardiac risk factors, overall body morphometrics, body composition as assessed by dual energy x-ray absorptiometry (DXA), and cancer control (PSA levels)
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Greater Los Angeles VA Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Stephen J Freedland, MD
role: PRINCIPAL_INVESTIGATOR
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