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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: CLIPP

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

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85714
      • University of Arizona School of Medicine Collaboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; 24 Week Lifestyle Modification intervention	Behavioral: CLIPP; Diabetes Prevention program and Comprehensive Lifestyle Improvement Program consisting of low calorie diet, physical activity, sleep optimization and stress management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach Recruiting Target	Recruit 30 men with prostate cancer who have been on androgen deprivation therapy within the last 5 years.	6 Months
Retention of Participants	80% retention rate, or 24 out of 30 participants	6 months
Adherence to Intervention	75% attendance rate throughout 24 intervention visits	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting Glucose	Unit of Measure Mg/dL	6 Months
Lipid Panel	Unit of Measure Mg/dL	6 Months
Hemoglobin A1c	Unit of Measure %	6 Months
Global Quality of Life Questionnaire	PROMIS Scale v 1.2 Global Health. Scale Measurements 1 to 5. 1=Poor 2=Fair 3=Good 4=Very Good 5= Excellent	6 Months
Specific Quality of Life Questionnaire	Expanded Prostate Cancer Index Composite Short Form (EPIC-26) - Scale of Measurement 0 to 4. 0=No Problem 1=Very Small problem 2=Small Problem 3=Moderate problem 4=Big Problem	6 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory pathways associated with Prostate Cancer Progression.	Inflammation markers measured will include Interleukin-6, Interleukin 1-beta, Interleukin-8, stromal cell derived factor 1-alpha & basic fibroblast growth factor.	6 Months
Angiogenic pathways associated with prostate cancer progression	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

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Amit Algotar, MD, University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2018
• Primary Completion (Actual): December 19, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: October 15, 2018
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (Actual): June 27, 2019

Study Record Updates

• Last Update Posted (Actual): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 10, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 1806697620

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No