Prostate Cancer Clinical Trial
— CLIPP2Official title:
Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer2 (CLIPP2)
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.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | October 31, 2022 |
Est. primary completion date | February 28, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years to 80 Years |
Eligibility | 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% |
Country | Name | City | State |
---|---|---|---|
United States | Banner MD Anderson Cancer Center | Gilbert | Arizona |
United States | University of Arizona Cancer Center | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
University of Arizona | M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Inflammatory Pathways Associated with Prostate Cancer | Inflammation markers measured will include Interleukin-6, Interleukin 1-beta, Interleukin-8, stromal cell derived factor 1-alpha & basic fibroblast growth factor. | 6 Months | |
Other | Angiogenic Pathways Associated with Prostate Cancer | Determine the effect of comprehensive lifestyle modification intervention on angiogenesis, markers, important mechanisms for prostate cancer progression using blood, serum and urine. Angiogenesis markers will include vascular endothelial growth factor & plasma placental growth factor using Enzyme Linked Immunosorbent Assay (ELISA) | 6 Months | |
Primary | Reach Recruiting Target | Recruit 36 men with prostate cancer who have been on androgen deprivation therapy within the last 5 years. | 6 Months | |
Primary | Retention of Participants | 75% retention rate | 6 Months | |
Primary | Adherence to Intervention | 75% attendance rate throughout 24 intervention visits | 6 Months | |
Secondary | Fasting Glucose | Unit of Measure Mg/dL | 6 Months | |
Secondary | Lipid Panel | Unit of Measure Mg/dl | 6 Months | |
Secondary | Hemoglobin A1c | Unit of Measure % | 6 Months | |
Secondary | CBC | Unit of Measure Mg/dL | 6 Months | |
Secondary | CMP | Unit of Measure Mg/dL | 6 Months | |
Secondary | Global Quality of Life Questionnaire | PROMIS Scale v 1.2 Global Health. Scale Measurements 1 to 5 1=Poor 5=Excellent | 6 Months | |
Secondary | Specific Quality of Life Questionnaire | Expanded Prostate Cancer Index Composite Short Form (EPIC-26) Scale of Measurement 0 to 4. 0=No Problem 4=Big Problem | 6 Months |
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