Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer2 (CLIPP2)

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 24 Weeks Health Coaching Weekly Serum & Urine Baseline, Week 12 and Week 24 Anthropometric Measures Questionnaires BMI Measurements

Official Title
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Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer2 (CLIPP2)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: CLIPP2


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pre and Post Study Model
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLIPP2<br>24 Week Lifestyle Modification Intervention | Behavioral: CLIPP2<br>* Diabetes Prevention Program and Comprehensive Lifestyle Improvement Program with emphasis on a low carbohydrate and Keto diet, physical activity, sleep optimization and stress management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Glucose | Unit of Measure Mg/dL | 6 Months | 
| Lipid Panel | Unit of Measure Mg/dl | 6 Months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Carbohydrate, Ketogenic, Androgen Deprivation Therapy