Prostate CancerNCT01886677
Improving Energy Balance in Men With Prostate Cancer
A study testing Immediate diet and exercise intervention and Delayed diet and exercise intervention in people with Prostate Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
RATIONALE: Obesity and overweight are associated with the risk of aggressive disease, and energy balance may play a major role in prostate cancer progression. PURPOSE: Randomized phase II trial to study the effectiveness of weight loss, via a healthy energy-restricted diet and exercise, in slowing or preventing… Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Immediate diet and exercise intervention and Delayed diet and exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jan 2015
- 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 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed prostate cancer
- Elects prostatectomy as first line treatment (i.e., no androgen ablation, radiation therapy, etc)
- Has at least 3.5 weeks lag-time until scheduled prostatectomy (must be able to participate in the diet and exercise program a full 3.5 weeks).
- Body mass index (BMI) 25 - 49.9
- Mentally competent
- Able to speak and write English
- Has telephone access
- Agrees to be randomized to either study arm (immediate or delayed diet and exercise program)
Who cannot join
- Another active malignancy (not including non-melanoma skin cancer)
- Medical conditions that affect weight (e.g., untreated thyroid disturbances
- Currently on a weight loss regimen
- Preexisting medical condition(s) that preclude adherence to unsupervised exercise, e.g., severe orthopedic conditions, scheduled for a hip or knee replacement, bone metastases, paralysis, dementia, untreated stage 3 hypertension, or unstable angina, heart attack, congestive heart failure or conditions that dictated hospitalization or oxygen within 6-mths, etc.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35294
About this study
Official title: Exploring the Impact of Negative Energy Balance in Men With Prostate Cancer
RATIONALE: Obesity and overweight are associated with the risk of aggressive disease, and energy balance may play a major role in prostate cancer progression.
PURPOSE: Randomized phase II trial to study the effectiveness of weight loss, via a healthy energy-restricted diet and exercise, in slowing or preventing disease progression in patients who have newly diagnosed prostate cancer.
Read the detailed description
This is a 2-arm randomized controlled feasibility trial among 40 overweight or obese men newly diagnosed with prostate cancer who are scheduled for prostatectomy. This study will use the presurgical period to explore the potential impact of weight loss via a healthy energy-restricted diet and increased physical activity on circulating hormones, cytokines, and growth factors, as well as effects on tumor biology and other clinical outcomes. Consenting patients will be block randomized to 1-of-2 study arms: 1) a healthful diet + exercise intervention to promote a weight loss of up to 2 pounds/week; or 2) a wait-list control who will receive the intervention once the study period is complete. Both groups will receive nutritional counseling during the study period to correct nutritional deficiencies with food sources. This study will explore and contrast changes in body mass index (BMI) observed over the study period (minimum of 3.5 weeks) in the intervention vs. wait-list control arms, and also monitor changes in body composition, energy intake and physical activity; these changes will be studied in relation to the following endpoints: a) changes in select circulating biomarkers and gene expression related to cancer progression, hormonal status, inflammation and other energy-related factors; b) rates of tumor proliferation and apoptosis; c) tumor immunohistochemical markers of insulin receptor, vascular endothelial growth factor (VEGF), AKT, and nuclear factor kappa-light-chain-enhancer of activated B cells (NFkB); and d) functional and health-related outcomes, i.e., side-effects and medical outcomes, quality of life (QoL), and functional status.
- Conditions
- Prostate Cancer
- Being tested
- Immediate diet and exercise intervention, Delayed diet and exercise intervention
- Keywords
- prostate cancer, intervention, diet, physical activity, exercise, weight loss, biomarkers, cancer progression
- Medical subject headings
- Prostatic Neoplasms, Motor Activity, Weight Loss, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate diet and exercise interventionBehavioural
Both arms will receive the same intervention: a healthful diet plus exercise intervention to promote a weight loss of up to 2 pounds/week. The only difference is the timing of the delivery of the intervention (immediate vs. delayed).
Delayed diet and exercise interventionBehavioural
Both arms will receive the same intervention: a healthful diet plus exercise intervention to promote a weight loss of up to 2 pounds/week. The only difference is the timing of the delivery of the intervention (immediate vs. delayed).
| Study group | Role | What they receive |
|---|---|---|
| Immediate diet and exercise intervention | Experimental | A healthful diet plus exercise intervention to promote a weight loss of up to 2 pounds/week Receives: Behavioral: Immediate diet and exercise intervention |
| Delayed diet and exercise intervention | Other | This arm will receive the same diet and exercise intervention as the experimental arm once recovery from prostatectomy is achieved. Receives: Behavioral: Delayed diet and exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Proliferation Rate (Ki-67)
Changes in tumor proliferation rate (Ki-67) over the presurgical study period (minimum of 3.5 weeks, up to 24 weeks) will be explored and compared between the intervention and wait-list control arms.
Measured: Participants will be followed until their prostatectomy (minimum of 3.5 weeks, up to 24 weeks)
Secondary outcomes (1)
Changes in body weight and composition, energy intake and physical activity
Changes in body composition, energy intake and physical activity over the presurgical study period (minimum of 3.5 weeks, up to 24 weeks) will be explored and compared between the intervention and wait-list control arms.
Measured: Participants will be followed until their prostatectomy (minimum of 3.5 weeks, up to 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startSep 2012
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Wendy Demark-Wahnefried, PhD, University of Alabama at Birmingham
- Investigators
- Wendy Demark-Wahnefried, PhD, RD, Principal investigator, University of Alabama at Birmingham (UAB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886677
- Sponsor's protocol ID
- R21CA161263-01A1
- Status last verified
- Dec 2014
- First submitted
- 19 Jun 2013
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Demark-Wahnefried W, Nix JW, Hunter GR, Rais-Bahrami S, Desmond RA, Chacko B, Morrow CD, Azrad M, Fruge AD, Tsuruta Y, Ptacek T, Tully SA, Segal R, Grizzle WE. Erratum to: Feasibility outcomes of a presurgical randomized controlled trial exploring the impact of caloric restriction and increased physical activity versus a wait-list control on tumor characteristics and circulating biomarkers in men electing prostatectomy for prostate cancer. BMC Cancer. 2017 Jan 23;17(1):71. doi: 10.1186/s12885-016-3025-3. No abstract available.
PubMed 28114897Smith KS, Fruge AD, van der Pol W, Caston NE, Morrow CD, Demark-Wahnefried W, Carson TL. Gut microbial differences in breast and prostate cancer cases from two randomised controlled trials compared to matched cancer-free controls. Benef Microbes. 2021 Jun 15;12(3):239-248. doi: 10.3920/BM2020.0098. Epub 2021 Apr 1.
PubMed 33789551Fruge AD, Dasher JA, Bryan D, Rais-Bahrami S, Demark-Wahnefried W, Hunter GR. Physiological Effort in Submaximal Fitness Tests Predicts Weight Loss in Overweight and Obese Men with Prostate Cancer in a Weight Loss Trial. Int J Cancer Clin Res. 2017;4(2):083. doi: 10.23937/2378-3419/1410083. Epub 2017 Oct 16.
PubMed 29546247Fruge AD, Ptacek T, Tsuruta Y, Morrow CD, Azrad M, Desmond RA, Hunter GR, Rais-Bahrami S, Demark-Wahnefried W. Dietary Changes Impact the Gut Microbe Composition in Overweight and Obese Men with Prostate Cancer Undergoing Radical Prostatectomy. J Acad Nutr Diet. 2018 Apr;118(4):714-723.e1. doi: 10.1016/j.jand.2016.10.017. Epub 2016 Dec 15.
PubMed 27988219Demark-Wahnefried W, Nix JW, Hunter GR, Rais-Bahrami S, Desmond RA, Chacko B, Morrow CD, Azrad M, Fruge AD, Tsuruta Y, Ptacek T, Tully SA, Segal R, Grizzle WE. Feasibility outcomes of a presurgical randomized controlled trial exploring the impact of caloric restriction and increased physical activity versus a wait-list control on tumor characteristics and circulating biomarkers in men electing prostatectomy for prostate cancer. BMC Cancer. 2016 Feb 5;16:61. doi: 10.1186/s12885-016-2075-x.
PubMed 26850040
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Impact of Negative Energy Balance in Men With Prostate Cancer
- ClinicalTrials.gov ID
- NCT01886677
- Acronym / sponsor ID
- R21CA161263-01A1
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, intervention, diet, physical activity, exercise, weight loss, biomarkers, cancer progression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 26 Jun 2013 (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.
RATIONALE: Obesity and overweight are associated with the risk of aggressive disease, and energy balance may play a major role in prostate cancer progression.
PURPOSE: Randomized phase II trial to study the effectiveness of weight loss, via a healthy energy-restricted diet and exercise, in slowing or preventing disease progression in patients who have newly diagnosed prostate cancer.
Detailed description
This is a 2-arm randomized controlled feasibility trial among 40 overweight or obese men newly diagnosed with prostate cancer who are scheduled for prostatectomy. This study will use the presurgical period to explore the potential impact of weight loss via a healthy energy-restricted diet and increased physical activity on circulating hormones, cytokines, and growth factors, as well as effects on tumor biology and other clinical outcomes. Consenting patients will be block randomized to 1-of-2 study arms: 1) a healthful diet + exercise intervention to promote a weight loss of up to 2 pounds/week; or 2) a wait-list control who will receive the intervention once the study period is complete. Both groups will receive nutritional counseling during the study period to correct nutritional deficiencies with food sources. This study will explore and contrast changes in body mass index (BMI) observed over the study period (minimum of 3.5 weeks) in the intervention vs. wait-list control arms, and also monitor changes in body composition, energy intake and physical activity; these changes will be studied in relation to the following endpoints: a) changes in select circulating biomarkers and gene expression related to cancer progression, hormonal status, inflammation and other energy-related factors; b) rates of tumor proliferation and apoptosis; c) tumor immunohistochemical markers of insulin receptor, vascular endothelial growth factor (VEGF), AKT, and nuclear factor kappa-light-chain-enhancer of activated B cells (NFkB); and d) functional and health-related outcomes, i.e., side-effects and medical outcomes, quality of life (QoL), and functional status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate diet and exercise intervention | Experimental | Behavioral: Immediate diet and exercise interventionA healthful diet plus exercise intervention to promote a weight loss of up to 2 pounds/week |
| Delayed diet and exercise intervention | Other | Behavioral: Delayed diet and exercise interventionThis arm will receive the same diet and exercise intervention as the experimental arm once recovery from prostatectomy is achieved. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histopathologically confirmed prostate cancer
- Elects prostatectomy as first line treatment (i.e., no androgen ablation, radiation therapy, etc)
- Has at least 3.5 weeks lag-time until scheduled prostatectomy (must be able to participate in the diet and exercise program a full 3.5 weeks).
- Body mass index (BMI) 25 - 49.9
- Mentally competent
Key exclusion criteria (4 listed)
- Another active malignancy (not including non-melanoma skin cancer)
- Medical conditions that affect weight (e.g., untreated thyroid disturbances
- Currently on a weight loss regimen
- Preexisting medical condition(s) that preclude adherence to unsupervised exercise, e.g., severe orthopedic conditions, scheduled for a hip or knee replacement, bone metastases, paralysis, dementia, untreated stage 3 hypertension, or unstable angina, heart attack, congestive heart failure or conditions that dictated hospitalization or oxygen within 6-mths, etc.
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 |
|---|---|---|
| Immediate diet and exercise interventionBoth arms will receive the same intervention: a healthful diet plus exercise intervention to promote a weight loss of up to 2 pounds/week. The only difference is the timing of the delivery of the intervention (immediate vs. delayed). | Behavioural | Immediate diet and exercise intervention |
| Delayed diet and exercise interventionBoth arms will receive the same intervention: a healthful diet plus exercise intervention to promote a weight loss of up to 2 pounds/week. The only difference is the timing of the delivery of the intervention (immediate vs. delayed). | Behavioural | Delayed diet and exercise intervention |
Primary outcome
Tumor Proliferation Rate (Ki-67)
Time frame: Participants will be followed until their prostatectomy (minimum of 3.5 weeks, up to 24 weeks)
Changes in tumor proliferation rate (Ki-67) over the presurgical study period (minimum of 3.5 weeks, up to 24 weeks) will be explored and compared between the intervention and wait-list control arms.
1 secondary outcome
Changes in body weight and composition, energy intake and physical activity
Time frame: Participants will be followed until their prostatectomy (minimum of 3.5 weeks, up to 24 weeks)
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 3 Mar 2017.
- Results publication: PubMed 28114897Demark-Wahnefried W, Nix JW, Hunter GR, Rais-Bahrami S, Desmond RA, Chacko B, Morrow CD, Azrad M, Fruge AD, Tsuruta Y, Ptacek T, Tully SA, Segal R, Grizzle WE. Erratum to: Feasibility outcomes of a presurgical randomized controlled trial exploring the impact of caloric restriction and increased physical activity versus a wait-list control on tumor characteristics and circulating biomarkers in men electing prostatectomy for prostate cancer. BMC Cancer. 2017 Jan 23;17(1):71. doi: 10.1186/s12885-016-3025-3. No abstract available.
- Derived from this study: PubMed 33789551Smith KS, Fruge AD, van der Pol W, Caston NE, Morrow CD, Demark-Wahnefried W, Carson TL. Gut microbial differences in breast and prostate cancer cases from two randomised controlled trials compared to matched cancer-free controls. Benef Microbes. 2021 Jun 15;12(3):239-248. doi: 10.3920/BM2020.0098. Epub 2021 Apr 1.
- Derived from this study: PubMed 29546247Fruge AD, Dasher JA, Bryan D, Rais-Bahrami S, Demark-Wahnefried W, Hunter GR. Physiological Effort in Submaximal Fitness Tests Predicts Weight Loss in Overweight and Obese Men with Prostate Cancer in a Weight Loss Trial. Int J Cancer Clin Res. 2017;4(2):083. doi: 10.23937/2378-3419/1410083. Epub 2017 Oct 16.
- Derived from this study: PubMed 27988219Fruge AD, Ptacek T, Tsuruta Y, Morrow CD, Azrad M, Desmond RA, Hunter GR, Rais-Bahrami S, Demark-Wahnefried W. Dietary Changes Impact the Gut Microbe Composition in Overweight and Obese Men with Prostate Cancer Undergoing Radical Prostatectomy. J Acad Nutr Diet. 2018 Apr;118(4):714-723.e1. doi: 10.1016/j.jand.2016.10.017. Epub 2016 Dec 15.
- Derived from this study: PubMed 26850040Demark-Wahnefried W, Nix JW, Hunter GR, Rais-Bahrami S, Desmond RA, Chacko B, Morrow CD, Azrad M, Fruge AD, Tsuruta Y, Ptacek T, Tully SA, Segal R, Grizzle WE. Feasibility outcomes of a presurgical randomized controlled trial exploring the impact of caloric restriction and increased physical activity versus a wait-list control on tumor characteristics and circulating biomarkers in men electing prostatectomy for prostate cancer. BMC Cancer. 2016 Feb 5;16:61. doi: 10.1186/s12885-016-2075-x.
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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.
Wendy Demark-Wahnefried, PhD, RD principal investigator
University of Alabama at Birmingham (UAB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate diet and exercise intervention and Delayed diet and exercise intervention in people with Prostate Cancer, run by University of Alabama at Birmingham at 1 site 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 4 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Tumor Proliferation Rate (Ki-67) (time frame: Participants will be followed until their prostatectomy (minimum of 3.5 weeks, up to 24 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01886677, which also lists 5 linked publications.
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 3 Mar 2017; AzTrials last refreshed its copy on 6 Nov 2026.