Atkins Diet and Prostate Cancer Clinical Trial - Full Text View

Sponsor:	Duke University
Collaborators:	VA Greater Los Angeles Healthcare System Durham VA Medical Center University of California, Los Angeles Santa Monica UCLA Medical Center
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00932672

Purpose

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).

Condition	Intervention	Phase
Prostate Cancer	Behavioral: Atkins Diet	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men Initiating Androgen Deprivation Therapy For Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Diabetes Medicines Prostate Cancer

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

The primary end-point will be differences in insulin sensitivity between the arms [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	June 2009
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Atkins group Men assigned to the Atkins diet will be asked to restrict carbohydrate intake to <20 grams/day. We will use an established clinical program directed by Dr. Eric Westman which implements this diet using a trained clinical nutritionist. No other dietary restrictions will be placed on the subjects. They will measure their urinary ketones at home weekly using urinary ketone strips. Subjects will meet with the nutritionist monthly during the first 6 months of the study and then every other month during the second 6 months of the study (i.e. months 8, 10, and 12). Subjects in the Atkins arm will also be asked to walk at a brisk pace for 30 minutes a day, 5 days a week and will be provided a pedometer to measure the number of steps taken per day.	Behavioral: Atkins Diet Patients are given an outline of the Atkins diet and are asked to follow it for 12 months Other Names: Atkins group Cases
No Intervention: Control group Subjects assigned to the waitlist control group will be asked to make no changes in their dietary habits. At the completion of the study (at month 12 and an 18-month follow-up), subjects will meet with the nutritionist and receive standard nutrition AHA recommendations.

Arms

Assigned Interventions

Experimental: Atkins group

Men assigned to the Atkins diet will be asked to restrict carbohydrate intake to <20 grams/day. We will use an established clinical program directed by Dr. Eric Westman which implements this diet using a trained clinical nutritionist. No other dietary restrictions will be placed on the subjects. They will measure their urinary ketones at home weekly using urinary ketone strips. Subjects will meet with the nutritionist monthly during the first 6 months of the study and then every other month during the second 6 months of the study (i.e. months 8, 10, and 12). Subjects in the Atkins arm will also be asked to walk at a brisk pace for 30 minutes a day, 5 days a week and will be provided a pedometer to measure the number of steps taken per day.

Behavioral: Atkins Diet

Patients are given an outline of the Atkins diet and are asked to follow it for 12 months

Other Names:

Atkins group
Cases

No Intervention: Control group

Subjects assigned to the waitlist control group will be asked to make no changes in their dietary habits. At the completion of the study (at month 12 and an 18-month follow-up), subjects will meet with the nutritionist and receive standard nutrition AHA recommendations.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the prostate
Either already receiving ADT with an anticipated continued duration of ≥ 6 months or scheduled to initiate ADT with an anticipated duration of ≥ 6 months
Overweight or obese (body mass index ≥ 25 kg/m2)

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932672

Contacts

Contact: Loretta A Taylor, B.S.

919-684-4896

loretta.taylor@duke.edu

Locations

United States, California
Greater Los Angeles VA Medical Center	Recruiting
Los Angeles, California, United States, 90073
Contact: Gail Thames 310-825-0453 gthames@mednet.ucla.edu
Principal Investigator: William Aronson, MD
University of California, Los Angeles	Recruiting
Los Angeles, California, United States, 90095
Contact: Gail Thames 310-825-0453 gthames@mednet.ucla.edu
Principal Investigator: William Aronson, MD
United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Loretta Taylor, B.S. 919-684-4896 loretta.taylor@duke.edu
Principal Investigator: Stephen J Freedland, MD

Sponsors and Collaborators

Duke University

VA Greater Los Angeles Healthcare System

Durham VA Medical Center

University of California, Los Angeles

Santa Monica UCLA Medical Center

Investigators

Principal Investigator:

Stephen J Freedland, MD

Duke University

More Information

Additional Information:

Atkins Diet Weight Loss Program This link exits the ClinicalTrials.gov site

Publications:

Loblaw DA, Virgo KS, Nam R, Somerfield MR, Ben-Josef E, Mendelson DS, Middleton R, Sharp SA, Smith TJ, Talcott J, Taplin M, Vogelzang NJ, Wade JL 3rd, Bennett CL, Scher HI; American Society of Clinical Oncology. Initial hormonal management of androgen-sensitive metastatic, recurrent, or progressive prostate cancer: 2006 update of an American Society of Clinical Oncology practice guideline. J Clin Oncol. 2007 Apr 20;25(12):1596-605. Epub 2007 Apr 2. Review.

Bolla M, Gonzalez D, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Gil T, Collette L, Pierart M. Improved survival in patients with locally advanced prostate cancer treated with radiotherapy and goserelin. N Engl J Med. 1997 Jul 31;337(5):295-300.

Smith MR, Lee H, Nathan DM. Insulin sensitivity during combined androgen blockade for prostate cancer. J Clin Endocrinol Metab. 2006 Apr;91(4):1305-8. Epub 2006 Jan 24.

Keating NL, O'Malley AJ, Smith MR. Diabetes and cardiovascular disease during androgen deprivation therapy for prostate cancer. J Clin Oncol. 2006 Sep 20;24(27):4448-56.

Tsai HK, D'Amico AV, Sadetsky N, Chen MH, Carroll PR. Androgen deprivation therapy for localized prostate cancer and the risk of cardiovascular mortality. J Natl Cancer Inst. 2007 Oct 17;99(20):1516-24. Epub 2007 Oct 9.

D'Amico AV, Chen MH, Renshaw AA, Loffredo M, Kantoff PW. Androgen suppression and radiation vs radiation alone for prostate cancer: a randomized trial. JAMA. 2008 Jan 23;299(3):289-95.

Saigal CS, Gore JL, Krupski TL, Hanley J, Schonlau M, Litwin MS; And the Urologic Diseases in America Project. Androgen deprivation therapy increases cardiovascular morbidity in men with prostate cancer. Cancer. 2007 Oct 1;110(7):1493-500.

Gardner CD, Kiazand A, Alhassan S, Kim S, Stafford RS, Balise RR, Kraemer HC, King AC. Comparison of the Atkins, Zone, Ornish, and LEARN diets for change in weight and related risk factors among overweight premenopausal women: the A TO Z Weight Loss Study: a randomized trial. JAMA. 2007 Mar 7;297(9):969-77.

Freedland SJ, Mavropoulos J, Wang A, Darshan M, Demark-Wahnefried W, Aronson WJ, Cohen P, Hwang D, Peterson B, Fields T, Pizzo SV, Isaacs WB. Carbohydrate restriction, prostate cancer growth, and the insulin-like growth factor axis. Prostate. 2008 Jan 1;68(1):11-9.

Yancy WS Jr, Olsen MK, Guyton JR, Bakst RP, Westman EC. A low-carbohydrate, ketogenic diet versus a low-fat diet to treat obesity and hyperlipidemia: a randomized, controlled trial. Ann Intern Med. 2004 May 18;140(10):769-77.

Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9.

Smith MR, Finkelstein JS, McGovern FJ, Zietman AL, Fallon MA, Schoenfeld DA, Kantoff PW. Changes in body composition during androgen deprivation therapy for prostate cancer. J Clin Endocrinol Metab. 2002 Feb;87(2):599-603.

Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403.

Barry MJ, Delorenzo MA, Walker-Corkery ES, Lucas FL, Wennberg DC. The rising prevalence of androgen deprivation among older American men since the advent of prostate-specific antigen testing: a population-based cohort study. BJU Int. 2006 Nov;98(5):973-8. Epub 2006 Jul 28.

Responsible Party:	Stephen J. Freedland, MD/Associate Professor of Urology and Pathology, Duke University Medical Center
ClinicalTrials.gov Identifier:	NCT00932672 History of Changes
Other Study ID Numbers:	00010519
Study First Received:	July 2, 2009
Last Updated:	August 19, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

Prostate Cancer
Atkins

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012