Clinical trial · Interventional
Energy Balance for Prostate Cancer Survivorship
NCT02252484CI-TRIAL-00023799completedN/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 evaluate the effectiveness of a weight management program for men undergoing a prostatectomy by seeing if the program is easy to follow, impacts weight gain, and reduces risk of cancer recurrence in the participants.
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 |
|---|---|---|---|
| Standard of Care | Other | — | UNRESOLVED |
| Weight Loss Program | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Weight loss intervention Group
- description
- Participants will receive tailor weight loss program. Participants will complete 8-weeks of the weight loss intervention prior to having their prostatectomy (weight loss phase). Program includes individual weight coaching, tailored diet and exercise plan, weight coaching and tracking of daily activities. Sessions will be held weekly during the weight loss phase. The groups will be facilitated by a registered dietitian with genitourinary (GU) oncology experience.
- interventionNames
- Other: Weight Loss Program
- type
- ACTIVE_COMPARATOR
- label
- Comparison Group
- description
- All patients who are unwilling or not ready to engage in a weight loss program will be offered entry into the comparison group arm.
- interventionNames
- Other: Standard of Care
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 72 Years
Show eligibility criteria text
Inclusion Criteria: * Men newly diagnosed with prostate cancer who are scheduled for prostatectomy (Stage T1 or T2) * Body Mass Index (BMI) 25-45 kg/m2 * Have internet access * Have an iPad/iPhone/iDevice Exclusion Criteria: * History of 5 alpha reductase inhibitors prior 3 months * History of radiation therapy * Taking active cancer treatment * Undergoing salvage therapy * Castration-resistant prostate cancer * Evidence of metastasis * Evidence of biochemical recurrence * High risk medical condition (e.g. gout or kidney disease)
References
Publications (1)
- DERIVEDHamilton-Reeves JM, Johnson CN, Hand LK, Bechtel MD, Robertson HL, Michel C, Metcalf M, Chalise P, Mahan NJ, Mirza M, Lee EK, Sullivan DK, Klemp JR, Befort CA, Parker WP, Gibbs HD, Demark-Wahnefried W, Thrasher JB. Feasibility of a Weight Management Program Tailored for Overweight Men with Localized Prostate Cancer - A Pilot Study. Nutr Cancer. 2021;73(11-12):2671-2686. doi: 10.1080/01635581.2020.1856890. Epub 2020 Dec 9. PMID 33295204