Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer — CLIPP  

Prostate Cancer Clinical Trial

Official title: Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer

Status Completed

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 30 prostate cancer survivors who have been on androgen deprivation therapy within the last 5 years for a lifestyle modification intervention.

Clinical Trial 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), 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

• Dual-energy X-ray absorptiometry (DXA) at Baseline and Week 24 ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT04000464
• Study type: Interventional
• Source: University of Arizona
• Status: Completed
• Phase: N/A
• Start date: October 9, 2018
• Completion date: December 30, 2019