Status:
COMPLETED
Eating, Activity, and Stress Education
Lead Sponsor:
University of South Carolina
Collaborating Sponsors:
United States Department of Defense
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether a vegetable-based diet, physical activity program, and stress reduction training will reduce or maintain PSA levels, an indicator of prostate cancer p...
Detailed Description
Following surgery or radiation of a primary early-stage prostate cancer (PrCA), one in three patients will experience an elevation in serum prostate antigen (PSA) within 10 years. For men whose primar...
Eligibility Criteria
Inclusion
- have a histologically confirmed diagnosis of adenocarcinoma of the prostate
- have been treated by radical prostatectomy or radiation therapy
- have had no malignancy in the past 5 years (except the primary prostate cancer for which initial treatment was sought and non malignant melanoma of the skin)
- not be taking thyroid medication, antibiotics, diuretics or steroids
- be able to read at a sixth grade level
- speak English as their first language
- be of sound mind, memory, and understanding as evaluated by recruitment staff
- have experienced a rise in serum PSA concentration after achieving a post surgery nadir, after achieving a post radiation nadir, or having had both a radical prostatectomy and subsequent radiotherapy
Exclusion
- has received high dose radiotherapy or brachytherapy in place of surgery as a primary treatment
- has received post-operative hormone therapy for prostate cancer
- received treatment of prostate cancer with an LH-RH analog
- has a diagnosis of cardiovascular, pulmonary, or metabolic disease or major symptoms of these diseases, including pain or discomfort in the chest, neck, jaw, arms or other areas that may be due to ischemia; shortness of breath or unusual fatigue at rest or with mild exertion; dizziness; dyspnea while sleeping; ankle edema or intermittent claudication; palpitations, tachycardia, or a known heart murmur
- has experienced a weight loss in excess of five pounds in the previous 3 months
- regularly consumes more than two alcoholic drinks per day
- plans on taking hormone supplements such as melatonin, or fish oil or other; supplements rich in omega-3 fatty acids
- has been diagnosed with Crohn's disease or has active ulcerative colitis
- has been diagnosed with Post Traumatic Stress Disorder (PTSD)
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01434004
Start Date
January 1 2003
End Date
July 1 2007
Last Update
April 18 2019
Active Locations (2)
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1
Palmetto Baptist Medical Center
Columbia, South Carolina, United States, 29201
2
Palmetto Richland Memorial Hospital
Columbia, South Carolina, United States, 29203