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Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer2 (CLIPP2) (CLIPP2)

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ClinicalTrials.gov Identifier: NCT04228055
Recruitment Status : Recruiting
First Posted : January 14, 2020
Last Update Posted : September 28, 2020
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
University of Arizona

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: CLIPP2 Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pre and Post Study Model
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer2 (CLIPP2)
Actual Study Start Date : August 7, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: CLIPP2
24 Week Lifestyle Modification Intervention
 Behavioral: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Retention of Participants [ Time Frame: 6 Months ]
    75% retention rate

  3. Adherence to Intervention [ Time Frame: 6 Months ]
    75% attendance rate throughout 24 intervention visits


Secondary Outcome Measures :
  1. Fasting Glucose [ Time Frame: 6 Months ]
    Unit of Measure Mg/dL

  2. Lipid Panel [ Time Frame: 6 Months ]
    Unit of Measure Mg/dl

  3. Hemoglobin A1c [ Time Frame: 6 Months ]
    Unit of Measure %

  4. CBC [ Time Frame: 6 Months ]
    Unit of Measure Mg/dL

  5. CMP [ Time Frame: 6 Months ]
    Unit of Measure Mg/dL

  6. Global Quality of Life Questionnaire [ Time Frame: 6 Months ]
    PROMIS Scale v 1.2 Global Health. Scale Measurements 1 to 5 1=Poor 5=Excellent

  7. 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 4=Big Problem


Other Outcome Measures:
  1. Inflammatory Pathways Associated with Prostate Cancer [ 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.

  2. Angiogenic Pathways Associated with Prostate Cancer [ 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)


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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%
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04228055


Contacts
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Contact: Tracey Smith 5206268038 traceysmith@email.arizona.edu
Contact: Amit Algotar, MD, PhD, MPH 5206268038 algotar@email.arizona.edu

Locations
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United States, Arizona
Banner MD Anderson Cancer Center Recruiting
Gilbert, Arizona, United States, 85234
Contact: Tracey Smith    520-626-8038    traceysmith@arizona.edu   
University of Arizona Cancer Center Not yet recruiting
Tucson, Arizona, United States, 85714
Contact: Tracey Smith    520-626-8038    traceysmith@email.arizona.edu   
Principal Investigator: Amit Algotar, MD         
Sponsors and Collaborators
University of Arizona
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Amit Algotar, MD, PhD, MPH University of Arizona
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT04228055    
Other Study ID Numbers: 1806697620-2
First Posted: January 14, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Arizona:
Low Carbohydrate
Ketogenic
Androgen Deprivation Therapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases