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

Prostate Cancer Clinical Trial

— CLIPP2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04228055
• Other study ID #: 1806697620-2
• Status: Recruiting
• Phase: N/A
• Start date: August 7, 2020
• Est. completion date: October 31, 2022

Study information

• Verified date: August 2021
• Source: University of Arizona
• Contact: Tracey Smith
• Phone: 5206268038
• Email: traceysmith[@]email.arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• 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%

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• CLIPP2
Diabetes Prevention Program and Comprehensive Lifestyle Improvement Program with emphasis on a low carbohydrate and Keto diet, physical activity, sleep optimization and stress management.

Locations

Country	Name	City	State
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	University of Arizona Cancer Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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