Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
Not provided
Not provided
Not provided
Not provided
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 30 prostate cancer survivors who have been on androgen deprivation therapy within the last 5 years for a lifestyle modification intervention.
Introduction
Intervention:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | 24 Week Lifestyle Modification intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLIPP | Behavioral | Diabetes Prevention program and Comprehensive Lifestyle Improvement Program consisting of low calorie diet, physical activity, sleep optimization and stress management |
| Measure | Description | Time Frame |
|---|---|---|
| Reach Recruiting Target | Recruit 30 men with prostate cancer who have been on androgen deprivation therapy within the last 5 years. | 6 Months |
| Retention of Participants | 80% retention rate, or 24 out of 30 participants | 6 months |
| Adherence to Intervention | 75% attendance rate throughout 24 intervention visits | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Glucose | Unit of Measure Mg/dL | 6 Months |
| Lipid Panel | Unit of Measure Mg/dL | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory pathways associated with Prostate Cancer Progression. | Inflammation markers measured will include Interleukin-6, Interleukin 1-beta, Interleukin-8, stromal cell derived factor 1-alpha & basic fibroblast growth factor. | 6 Months |
| Angiogenic pathways associated with prostate cancer progression |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amit Algotar, MD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona School of Medicine Collaboratory | Tucson | Arizona | 85714 | United States |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Pre and Post study model
Not provided
Not provided
Not provided
Not provided
| Hemoglobin A1c | Unit of Measure % | 6 Months |
| Global Quality of Life Questionnaire | PROMIS Scale v 1.2 Global Health. Scale Measurements 1 to 5. 1=Poor 2=Fair 3=Good 4=Very Good 5= Excellent | 6 Months |
| Specific Quality of Life Questionnaire | Expanded Prostate Cancer Index Composite Short Form (EPIC-26) - Scale of Measurement 0 to 4. 0=No Problem 1=Very Small problem 2=Small Problem 3=Moderate problem 4=Big Problem | 6 Months |
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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |