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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Diabetes Prevention Program and Comprehensive Lifestyle Improvement Program with emphasis on a low carbohydrate and Keto diet, physical activity, sleep optimization and stress management.
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
RECRUITINGUniversity of Arizona Cancer Center
Tucson, Arizona, United States
NOT_YET_RECRUITINGReach Recruiting Target
Recruit 36 men with prostate cancer who have been on androgen deprivation therapy within the last 5 years.
Time frame: 6 Months
Retention of Participants
75% retention rate
Time frame: 6 Months
Adherence to Intervention
75% attendance rate throughout 24 intervention visits
Time frame: 6 Months
Fasting Glucose
Unit of Measure Mg/dL
Time frame: 6 Months
Lipid Panel
Unit of Measure Mg/dl
Time frame: 6 Months
Hemoglobin A1c
Unit of Measure %
Time frame: 6 Months
CBC
Unit of Measure Mg/dL
Time frame: 6 Months
CMP
Unit of Measure Mg/dL
Time frame: 6 Months
Global Quality of Life Questionnaire
PROMIS Scale v 1.2 Global Health. Scale Measurements 1 to 5 1=Poor 5=Excellent
Time frame: 6 Months
Specific Quality of Life Questionnaire
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Expanded Prostate Cancer Index Composite Short Form (EPIC-26) Scale of Measurement 0 to 4. 0=No Problem 4=Big Problem
Time frame: 6 Months