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| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
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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.
INTRODUCTION:
Androgen deprivation therapy (ADT) has been demonstrated to improve disease free and over-all survival in men with prostate cancer (PCa).
ADT for PCa is associated with adverse cardio-metabolic effects such as reduced libido, hot flashes, metabolic syndrome, diabetes, myocardial infarction and stroke. This reduces quality of life (QoL) and potentially affects mortality.
There is paucity of data regarding comprehensive lifestyle interventions in men on ADT for Pca. Existing studies used non-standardized interventions or lack data on metabolic risk factors.
CLIPP is designed to address these gaps by using an intervention modelled after the Diabetes Prevention Program (DPP) with an emphasis on low carbohydrate and a Keto Diet, a standardized multi-component intervention with demonstrated effectiveness in reducing diabetes risk factors that has been successfully adapted for multiple disease types including breast cancer.
INTERVENTION:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLIPP2 | Experimental | 24 Week Lifestyle Modification Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLIPP2 | Behavioral | Diabetes Prevention Program and Comprehensive Lifestyle Improvement Program with emphasis on a low carbohydrate and Keto diet, physical activity, sleep optimization and stress management. |
| Measure | Description | Time Frame |
|---|---|---|
| Reach Recruiting Target | Recruit 36 men with prostate cancer who have been on androgen deprivation therapy within the last 5 years. | 6 Months |
| Retention of Participants | 75% retention rate | 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 | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tracey Smith | Contact | 5206268038 | traceysmith@email.arizona.edu | |
| Amit Algotar, MD, PhD, MPH | Contact | 5206268038 | algotar@email.arizona.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amit Algotar, MD, PhD, MPH | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Recruiting | Gilbert | Arizona | 85234 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33511299 | Derived | Algotar 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. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Pre and Post Study Model
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| Hemoglobin A1c | Unit of Measure % | 6 Months |
| CBC | Unit of Measure Mg/dL | 6 Months |
| CMP | Unit of Measure Mg/dL | 6 Months |
| Global Quality of Life Questionnaire | PROMIS Scale v 1.2 Global Health. Scale Measurements 1 to 5 1=Poor 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 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 |
| University of Arizona Cancer Center | Not yet recruiting | Tucson | Arizona | 85714 | United States |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |