Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer2 (CLIPP2)
NCT ID: NCT04228055
Last Updated: 2021-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
36 participants
INTERVENTIONAL
2020-08-07
2022-10-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CLIPP2
24 Week Lifestyle Modification Intervention
CLIPP2
Diabetes Prevention Program and Comprehensive Lifestyle Improvement Program with emphasis on a low carbohydrate and Keto diet, physical activity, sleep optimization and stress management.
Interventions
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CLIPP2
Diabetes Prevention Program and Comprehensive Lifestyle Improvement Program with emphasis on a low carbohydrate and Keto diet, physical activity, sleep optimization and stress management.
Eligibility Criteria
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Inclusion Criteria
* 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 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%
40 Years
80 Years
MALE
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
University of Arizona
OTHER
Responsible Party
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Principal Investigators
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Amit Algotar, MD, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Algotar AM, Kumar R, Babiker HM, Dougherty ST, Hsu CH, Chow HH, Smith TE, Marrero DG, Courneya KS, Abraham I, Ligibel JA, Thomson CA. Protocol for a feasibility and early efficacy study of the Comprehensive Lifestyle Improvement Program for Prostate Cancer-2 (CLIPP2). Contemp Clin Trials Commun. 2021 Jan 13;21:100701. doi: 10.1016/j.conctc.2021.100701. eCollection 2021 Mar.
Other Identifiers
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1806697620-2
Identifier Type: -
Identifier Source: org_study_id
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