NCT04228055

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of Arizona · Academic / Other
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-08-07
• Primary completion: 2022-02-28
• Completion: 2022-10-31
• First posted: 2020-01-14
• Last updated: 2021-08-31

Locations

2 sites across 1 country: United States