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Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men Initiating Androgen Deprivation Therapy For Prostate Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men Initiating Androgen Deprivation Therapy For Prostate Cancer


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.


Inclusion Criteria:



1. Histologically confirmed adenocarcinoma of the prostate

2. Either already receiving ADT with an anticipated continued duration of ≥ 6 months or
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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Stephen J Freedland, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Institutional Review Board

Study ID:

Pro00010519

NCT ID:

NCT00932672

Start Date:

June 2009

Completion Date:

December 2014

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Atkins
  • Prostatic Neoplasms

Name

Location
Duke University Medical Center Durham, North Carolina  27710
University of California, Los Angeles Los Angeles, California  
Greater Los Angeles VA Medical Center Los Angeles, California  90073