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Completed

NCT Number: NCT04000464

Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer

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 30 prostate cancer survivors who have been on androgen deprivation therapy within the last 5 years for a lifestyle modification intervention.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–89 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona School of Medicine Collaboratory

Tucson, Arizona, 85714, United States

About this study

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), 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
  • Dual-energy X-ray absorptiometry (DXA) at Baseline and Week 24

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with prostate cancer Stage I, II or IV
  • 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 years of age or older

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

Treatment and study plan

CLIPP

Behavioral

Diabetes Prevention program and Comprehensive Lifestyle Improvement Program consisting of low calorie diet, physical activity, sleep optimization and stress management

Primary outcomes

  1. Reach Recruiting Target

    Time frame: 6 Months

    Recruit 30 men with prostate cancer who have been on androgen deprivation therapy within the last 5 years.

  2. Retention of Participants

    Time frame: 6 months

    80% retention rate, or 24 out of 30 participants

  3. Adherence to Intervention

    Time frame: 6 months

    75% attendance rate throughout 24 intervention visits

Secondary outcomes

  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. Global Quality of Life Questionnaire

    Time frame: 6 Months

    PROMIS Scale v 1.2 Global Health. Scale Measurements 1 to 5. 1=Poor 2=Fair 3=Good 4=Very Good 5= Excellent

  5. 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 1=Very Small problem 2=Small Problem 3=Moderate problem 4=Big Problem

Other outcomes

  1. Inflammatory pathways associated with Prostate Cancer Progression.

    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 progression

    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).

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Acronym: CLIPP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 27, 2019
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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