Eating, Activity, and Stress Education

Completed · Not applicable

Conditions studied: Prostate Cancer

In brief

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 progression, in men who have had their prostate gland removed following a prostate cancer diagnosis.

Key facts

Study ID

NCT01434004

Run by

University of South Carolina

People needed

58

Starts

2003-01-01

Expected to finish

2007-07-01

Last updated by the study team

2019-04-18

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Palmetto Baptist Medical Center — Columbia, South Carolina, United States
• Palmetto Richland Memorial Hospital — Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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