Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer

NCT ID: NCT04000464

Last Updated: 2020-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-09
• Study Completion Date: 2019-12-30

Brief 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.

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), 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

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

24 Week Lifestyle Modification intervention

Group Type: EXPERIMENTAL

CLIPP

Intervention Type: BEHAVIORAL

Diabetes Prevention program and Comprehensive Lifestyle Improvement Program consisting of low calorie diet, physical activity, sleep optimization and stress management

Interventions

CLIPP

Diabetes Prevention program and Comprehensive Lifestyle Improvement Program consisting of low calorie diet, physical activity, sleep optimization and stress management

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amit Algotar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

University of Arizona School of Medicine Collaboratory

Tucson, Arizona, United States

Countries

United States

Other Identifiers

1806697620

Identifier Type: -

Identifier Source: org_study_id