Clinical trial · Interventional
Eating, Activity, and Stress Education
A Diet, Physical Activity, and Meditation Intervention in Men With Rising Prostate-specific Antigen
NCT01434004CI-TRIAL-00038238EASEcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lifestyle counseling | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lifestyle counseling
- description
- Diet component: focus on increasing intake of whole grains, soybeans, soybean products, other beans, and vegetables. Physical Activity: encourage completion of morning exercise sessions. Mindfulness Stress Reduction: training in mindfulness meditation, including dealing with intensive physical symptoms and difficult emotional situations.
- interventionNames
- Behavioral: Lifestyle counseling
- type
- NO_INTERVENTION
- label
- Control group
- description
- Usual care (watchful waiting).
Primary outcomes (1)
- measure
- Change in prostate-specific antigen from baseline
- timeFrame
- baseline, 3 months, 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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)
References
Publications (0)
Data not yet available
No reference posted for this study.