Atkins Diet and Prostate Cancer Clinical Trial

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00932672
• Other study ID #: Pro00010519
• Status: Terminated
• Phase: Phase 2
• First received: July 2, 2009
• Last updated: December 4, 2015
• Start date: June 2009
• Est. completion date: October 2014

Study information

• Verified date: December 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Greater Los Angeles VA Medical Center	Los Angeles	California
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (6)

Lead Sponsor	Collaborator
Duke University	Carolina Urologic Research Center, Durham VA Medical Center, First Urology, University of California, Los Angeles, VA Greater Los Angeles Healthcare System

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. doi: 10.1001/jama.299.3.289. — View Citation

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. — View Citation

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. Erratum in: JAMA. 2007 Jul 11;298(2):178. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary end-point will be differences in insulin sensitivity between the arms		6 months	No
Secondary	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)		6 months	No

External Links

•   Atkins Diet Weight Loss Program