Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer2 (CLIPP2)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Arizona
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Retention of Participants
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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%
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
- •Subjects already following an intensive lifestyle modification plan
- •BMI <25%
Arms & Interventions
CLIPP2
24 Week Lifestyle Modification Intervention
Intervention: CLIPP2 (Behavioral)
Outcomes
Primary Outcomes
Retention of Participants
Time Frame: 6 Months
75% retention rate
Adherence to Intervention
Time Frame: 6 Months
75% attendance rate throughout 24 intervention visits
Reach Recruiting Target
Time Frame: 6 Months
Recruit 36 men with prostate cancer who have been on androgen deprivation therapy within the last 5 years.
Secondary Outcomes
- Lipid Panel(6 Months)
- Fasting Glucose(6 Months)
- Hemoglobin A1c(6 Months)
- CBC(6 Months)
- Global Quality of Life Questionnaire(6 Months)
- Specific Quality of Life Questionnaire(6 Months)
- CMP(6 Months)