Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer2 (CLIPP2) (CLIPP2)
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|ClinicalTrials.gov Identifier: NCT04228055|
Recruitment Status : Recruiting
First Posted : January 14, 2020
Last Update Posted : August 31, 2021
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Behavioral: CLIPP2||Not Applicable|
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.
- 24 Weeks
- Health Coaching Weekly
- Serum & Urine Baseline, Week 12 and Week 24
- Anthropometric Measures
- BMI Measurements
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Pre and Post Study Model|
|Masking:||None (Open Label)|
|Official Title:||Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer2 (CLIPP2)|
|Actual Study Start Date :||August 7, 2020|
|Estimated Primary Completion Date :||February 28, 2022|
|Estimated Study Completion Date :||October 31, 2022|
24 Week Lifestyle Modification Intervention
Diabetes Prevention Program and Comprehensive Lifestyle Improvement Program with emphasis on a low carbohydrate and Keto diet, physical activity, sleep optimization and stress management.
- Reach Recruiting Target [ Time Frame: 6 Months ]Recruit 36 men with prostate cancer who have been on androgen deprivation therapy within the last 5 years.
- Retention of Participants [ Time Frame: 6 Months ]75% retention rate
- Adherence to Intervention [ Time Frame: 6 Months ]75% attendance rate throughout 24 intervention visits
- Fasting Glucose [ Time Frame: 6 Months ]Unit of Measure Mg/dL
- Lipid Panel [ Time Frame: 6 Months ]Unit of Measure Mg/dl
- Hemoglobin A1c [ Time Frame: 6 Months ]Unit of Measure %
- CBC [ Time Frame: 6 Months ]Unit of Measure Mg/dL
- CMP [ Time Frame: 6 Months ]Unit of Measure Mg/dL
- Global Quality of Life Questionnaire [ Time Frame: 6 Months ]PROMIS Scale v 1.2 Global Health. Scale Measurements 1 to 5 1=Poor 5=Excellent
- Specific Quality of Life Questionnaire [ Time Frame: 6 Months ]Expanded Prostate Cancer Index Composite Short Form (EPIC-26) Scale of Measurement 0 to 4. 0=No Problem 4=Big Problem
- Inflammatory Pathways Associated with Prostate Cancer [ Time Frame: 6 Months ]Inflammation markers measured will include Interleukin-6, Interleukin 1-beta, Interleukin-8, stromal cell derived factor 1-alpha & basic fibroblast growth factor.
- Angiogenic Pathways Associated with Prostate Cancer [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04228055
|Contact: Tracey Smithfirstname.lastname@example.org|
|Contact: Amit Algotar, MD, PhD, MPHemail@example.com|
|United States, Arizona|
|Banner MD Anderson Cancer Center||Recruiting|
|Gilbert, Arizona, United States, 85234|
|Contact: Tracey Smith 520-626-8038 firstname.lastname@example.org|
|University of Arizona Cancer Center||Not yet recruiting|
|Tucson, Arizona, United States, 85714|
|Contact: Tracey Smith 520-626-8038 email@example.com|
|Principal Investigator: Amit Algotar, MD|
|Principal Investigator:||Amit Algotar, MD, PhD, MPH||University of Arizona|