Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer2 (CLIPP2)
- Conditions
- Prostate Cancer
- Interventions
- Behavioral: CLIPP2
- Registration Number
- NCT04228055
- Lead Sponsor
- University of Arizona
- 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 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 36
- Diagnosed with prostate cancer Stage I, II or III
- 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 to 80 years of age
- BMI >25%
- 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
- Subjects already following an intensive lifestyle modification plan
- BMI <25%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CLIPP2 CLIPP2 24 Week Lifestyle Modification Intervention
- Primary Outcome Measures
Name Time Method Retention of Participants 6 Months 75% retention rate
Adherence to Intervention 6 Months 75% attendance rate throughout 24 intervention visits
Reach Recruiting Target 6 Months Recruit 36 men with prostate cancer who have been on androgen deprivation therapy within the last 5 years.
- Secondary Outcome Measures
Name Time Method Lipid Panel 6 Months Unit of Measure Mg/dl
Fasting Glucose 6 Months Unit of Measure Mg/dL
Hemoglobin A1c 6 Months Unit of Measure %
CBC 6 Months Unit of Measure Mg/dL
Global Quality of Life Questionnaire 6 Months PROMIS Scale v 1.2 Global Health. Scale Measurements 1 to 5 1=Poor 5=Excellent
Specific Quality of Life Questionnaire 6 Months Expanded Prostate Cancer Index Composite Short Form (EPIC-26) Scale of Measurement 0 to 4. 0=No Problem 4=Big Problem
CMP 6 Months Unit of Measure Mg/dL
Trial Locations
- Locations (2)
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States