Clinical trial · Interventional
Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer2 (CLIPP2)
NCT04228055CI-TRIAL-00053602CLIPP2unknownN/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)
This study is an investigator initiated clinical study. A prospective, single arm unblinded, open label study will be carried out to determine the feasibility of recruitment, retention and adherence of 36 prostate cancer survivors who have been on androgen deprivation therapy within the last 5 years for a lifestyle modification intervention.
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 |
|---|---|---|---|
| CLIPP2 | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CLIPP2
- description
- 24 Week Lifestyle Modification Intervention
- interventionNames
- Behavioral: CLIPP2
Primary outcomes (3)
- measure
- Reach Recruiting Target
- timeFrame
- 6 Months
- description
- Recruit 36 men with prostate cancer who have been on androgen deprivation therapy within the last 5 years.
- measure
- Retention of Participants
- timeFrame
- 6 Months
- description
- 75% retention rate
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with prostate cancer Stage I, II or III * On androgen deprivation therapy with last 5 years * Willing to participate in a lifestyle modification program * Willing to modify diet and eating practices * Willing to participate in blood collection, urine collection and measurements * Minimum of 30 days since participating in another study/trial * English speaking * 40 to 80 years of age * BMI \>25% Exclusion Criteria: * Currently participating in another study or trial * Currently in hospice * Inability to walk two city blocks * Inability to comprehend informed consent or procedural requirements * Digestive Diseases (IBD, Diverticulitis, etc) that might prevent him from increasing fruit and vegetable intake * Subjects already following an intensive lifestyle modification plan * BMI \<25%
References
Publications (1)
- DERIVEDAlgotar AM, Kumar R, Babiker HM, Dougherty ST, Hsu CH, Chow HH, Smith TE, Marrero DG, Courneya KS, Abraham I, Ligibel JA, Thomson CA. Protocol for a feasibility and early efficacy study of the Comprehensive Lifestyle Improvement Program for Prostate Cancer-2 (CLIPP2). Contemp Clin Trials Commun. 2021 Jan 13;21:100701. doi: 10.1016/j.conctc.2021.100701. eCollection 2021 Mar. PMID 33511299