Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer (CLIPP)

University of Arizona

Status

Completed

Conditions

Prostate Cancer

Treatments

Behavioral: CLIPP

Study type

Interventional

Funder types

Other

Identifiers

NCT04000464

1806697620

Details and patient eligibility

About

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.

Full 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

Enrollment

31 patients

Sex

Male

Ages

40 to 89 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosed with prostate cancer Stage I, II or IV
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 years of age or older

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