Atkins Diet and Prostate Cancer Clinical Trial

Phase 2TerminatedNCT00932672

Duke University45 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Atkins DietBEHAVIORAL

Patients are given an outline of the Atkins diet and are asked to follow it for 6 months

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Greater Los Angeles VA Medical Center

Los Angeles, California, United States

University of California, Los Angeles

Los Angeles, California, United States

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

The primary end-point will be differences in insulin sensitivity between the arms

Time frame: 6 months

Secondary Outcomes

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)

Time frame: 6 months

Data from ClinicalTrials.gov

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