Clinical trial · Interventional
Improving Energy Balance in Men With Prostate Cancer
Exploring the Impact of Negative Energy Balance in Men With Prostate Cancer
NCT01886677CI-TRIAL-00026254completedN/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)
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.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Delayed diet and exercise intervention | Behavioral | — | UNRESOLVED |
| Immediate diet and exercise intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Immediate diet and exercise intervention
- description
- A healthful diet plus exercise intervention to promote a weight loss of up to 2 pounds/week
- interventionNames
- Behavioral: Immediate diet and exercise intervention
- type
- OTHER
- label
- Delayed diet and exercise intervention
- description
- This arm will receive the same diet and exercise intervention as the experimental arm once recovery from prostatectomy is achieved.
- interventionNames
- Behavioral: Delayed diet and exercise intervention
Primary outcomes (1)
- measure
- Tumor Proliferation Rate (Ki-67)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * 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) Exclusion Criteria: * 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.
References
Publications (5)
- RESULTDemark-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. PMID 28114897
- DERIVEDSmith 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. PMID 33789551
- DERIVEDFruge 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. PMID 29546247
- DERIVEDFruge 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. PMID 27988219
- DERIVEDDemark-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.