Prostate CancerEASENCT01434004
Eating, Activity, and Stress Education
A study testing Lifestyle counseling in people with Prostate Cancer, run by University of South Carolina at 2 sites in United States.
Trial 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 progression, in men who have had their prostate gland removed following a prostate cancer diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2003to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Palmetto Baptist Medical Center
Columbia, South Carolina, 29201
Palmetto Richland Memorial Hospital
Columbia, South Carolina, 29203
About this study
Official title: A Diet, Physical Activity, and Meditation Intervention in Men With Rising Prostate-specific Antigen
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.
Read the 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 primary treatment was prostatectomy, a PSA rise virtually always signals the spread of PrCA. After such evidence of recurrence, the "standard" treatment is medical or surgical castration. Castration results in reducing the PSA about 85% of the time, but it makes no difference whether such treatment occurs before or after the appearance of clinical symptoms of recurrence. This time interval between the first rise in PSA and symptom appearance may be many years. The most salient fact, however, is that castration does not prolong men's lives and it is not certain whether it even meaningfully delays symptom appearance in men who receive the treatment at the first sign of biochemical recurrence. Castration also has significant side effects including osteoporosis (bone loss), decreased muscle mass, impotence, and urinary incontinence. Because PrCA is usually a disease of older men, many will succumb to other diseases before they ever develop a symptom related to metastatic PrCA. For this large fraction of men, a treatment with deleterious affects on quality of life and no clear overall survival benefit may not be a good choice. The protocol the investigators propose will be performed instead of medical or surgical castration, which is not medically indicated at this point in the course of PrCA. Castration can and will be offered to these men at the first clinical symptom or sign of metastatic cancer, at which time those men will come off this study. It also is important to note that if the intervention results in reductions in PSA then the investigators will offer it to all men who had been randomized to the control condition initially. The investigators will conduct this randomized study in 60 asymptomatic men who have undergone radical prostatectomy (removal of the prostate gland) as their primary therapy of biopsy-confirmed adenocarcinoma of the prostate and subsequently have been found to have rising PSA levels, indicating an early recurrence of the cancer. Half (30) of these men will be randomized to usual care (watchful waiting) and the other half to an intervention consisting of a vegetable-based diet, program of physical activity timed to the natural rhythm of the day (i.e., circadian, or "around the day" - basically to timing of their exercise to improve their sleep cycles), and mindfulness-based stress reduction (consisting of meditation and other stress-reducing techniques). The intervention will continue for three months, followed by monthly booster sessions for 9 months. Data will be collected on compliance with the intervention and other factors that could modify the intervention or confuse our interpretation of its effect. The overall goal of the study will be to see the effect of making these behavioral and attitudinal changes on PSA levels, an indicator of disease progression in these men. The therapies the investigators will study are completely non-toxic and behavioral in nature.
- Conditions
- Prostate Cancer
- Being tested
- Lifestyle counseling
- Keywords
- prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle counselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | 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. Receives: Behavioral: Lifestyle counseling |
| Control group | No intervention | Usual care (watchful waiting). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in prostate-specific antigen from baseline
PSA is measured at baseline, 3 months and 6 months. Change in PSA is the primary outcome measure.
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startJan 2003
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, James hebert, University of South Carolina
- Investigators
- James R Hebert, Sc.D., Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434004
- Sponsor's protocol ID
- DAMD17-03-1-0139
- Acronym
- EASE
- Status last verified
- Apr 2019
- First submitted
- 7 Sep 2011
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Diet, Physical Activity, and Meditation Intervention in Men With Rising Prostate-specific Antigen
- ClinicalTrials.gov ID
- NCT01434004
- Acronym / sponsor ID
- EASE / DAMD17-03-1-0139
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Jan 2003
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 14 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 primary treatment was prostatectomy, a PSA rise virtually always signals the spread of PrCA. After such evidence of recurrence, the "standard" treatment is medical or surgical castration. Castration results in reducing the PSA about 85% of the time, but it makes no difference whether such treatment occurs before or after the appearance of clinical symptoms of recurrence. This time interval between the first rise in PSA and symptom appearance may be many years. The most salient fact, however, is that castration does not prolong men's lives and it is not certain whether it even meaningfully delays symptom appearance in men who receive the treatment at the first sign of biochemical recurrence. Castration also has significant side effects including osteoporosis (bone loss), decreased muscle mass, impotence, and urinary incontinence. Because PrCA is usually a disease of older men, many will succumb to other diseases before they ever develop a symptom related to metastatic PrCA. For this large fraction of men, a treatment with deleterious affects on quality of life and no clear overall survival benefit may not be a good choice. The protocol the investigators propose will be performed instead of medical or surgical castration, which is not medically indicated at this point in the course of PrCA. Castration can and will be offered to these men at the first clinical symptom or sign of metastatic cancer, at which time those men will come off this study. It also is important to note that if the intervention results in reductions in PSA then the investigators will offer it to all men who had been randomized to the control condition initially. The investigators will conduct this randomized study in 60 asymptomatic men who have undergone radical prostatectomy (removal of the prostate gland) as their primary therapy of biopsy-confirmed adenocarcinoma of the prostate and subsequently have been found to have rising PSA levels, indicating an early recurrence of the cancer. Half (30) of these men will be randomized to usual care (watchful waiting) and the other half to an intervention consisting of a vegetable-based diet, program of physical activity timed to the natural rhythm of the day (i.e., circadian, or "around the day" - basically to timing of their exercise to improve their sleep cycles), and mindfulness-based stress reduction (consisting of meditation and other stress-reducing techniques). The intervention will continue for three months, followed by monthly booster sessions for 9 months. Data will be collected on compliance with the intervention and other factors that could modify the intervention or confuse our interpretation of its effect. The overall goal of the study will be to see the effect of making these behavioral and attitudinal changes on PSA levels, an indicator of disease progression in these men. The therapies the investigators will study are completely non-toxic and behavioral in nature.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Lifestyle counselingDiet 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. |
| Control group | No intervention | –Usual care (watchful waiting). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle counselingDiet 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. | Behavioural | Lifestyle counseling |
Primary outcome
Change in prostate-specific antigen from baseline
Time frame: baseline, 3 months, 6 months
PSA is measured at baseline, 3 months and 6 months. Change in PSA is the primary outcome measure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James R Hebert, Sc.D. principal investigator
University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle counseling in people with Prostate Cancer, run by University of South Carolina at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in prostate-specific antigen from baseline (time frame: baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.