- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04000464
Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer (CLIPP)
January 10, 2020 updated by: University of Arizona
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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85714
- University of Arizona School of Medicine Collaboratory
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Arm
24 Week Lifestyle Modification intervention
|
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
Time Frame: 6 Months
|
Recruit 30 men with prostate cancer who have been on androgen deprivation therapy within the last 5 years.
|
6 Months
|
Retention of Participants
Time Frame: 6 months
|
80% retention rate, or 24 out of 30 participants
|
6 months
|
Adherence to Intervention
Time Frame: 6 months
|
75% attendance rate throughout 24 intervention visits
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting Glucose
Time Frame: 6 Months
|
Unit of Measure Mg/dL
|
6 Months
|
Lipid Panel
Time Frame: 6 Months
|
Unit of Measure Mg/dL
|
6 Months
|
Hemoglobin A1c
Time Frame: 6 Months
|
Unit of Measure %
|
6 Months
|
Global Quality of Life Questionnaire
Time Frame: 6 Months
|
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
Time Frame: 6 Months
|
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.
Time Frame: 6 Months
|
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
Time Frame: 6 Months
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Amit Algotar, MD, University of Arizona
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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