NCT04228055

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

August 7, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

1.6 years

First QC Date

January 10, 2020

Last Update Submit

August 30, 2021

Conditions

Prostate Cancer

Keywords

Low CarbohydrateKetogenicAndrogen Deprivation Therapy

Outcome Measures

Primary Outcomes (3)

  • Reach Recruiting Target

    Recruit 36 men with prostate cancer who have been on androgen deprivation therapy within the last 5 years.

    6 Months

  • Retention of Participants

    75% retention rate

    6 Months

  • Adherence to Intervention

    75% attendance rate throughout 24 intervention visits

    6 Months

Secondary Outcomes (7)

  • Fasting Glucose

    6 Months

  • Lipid Panel

    6 Months

  • Hemoglobin A1c

    6 Months

  • CBC

    6 Months

  • CMP

    6 Months

  • +2 more secondary outcomes

Other Outcomes (2)

  • Inflammatory Pathways Associated with Prostate Cancer

    6 Months

  • Angiogenic Pathways Associated with Prostate Cancer

    6 Months

Study Arms (1)

CLIPP2

EXPERIMENTAL

24 Week Lifestyle Modification Intervention

Behavioral: CLIPP2

Interventions

CLIPP2BEHAVIORAL

Diabetes Prevention Program and Comprehensive Lifestyle Improvement Program with emphasis on a low carbohydrate and Keto diet, physical activity, sleep optimization and stress management.

CLIPP2

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • to 80 years of age
  • BMI \>25%

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

RECRUITING

University of Arizona Cancer Center

Tucson, Arizona, 85714, United States

NOT YET RECRUITING

Related Publications (1)

  • 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.

    PMID: 33511299DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Amit Algotar, MD, PhD, MPH

    University of Arizona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tracey Smith

CONTACT

5206268038traceysmith@email.arizona.edu

Amit Algotar, MD, PhD, MPH

CONTACT

5206268038algotar@email.arizona.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pre and Post Study Model
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2020

First Posted

January 14, 2020

Study Start

August 7, 2020

Primary Completion

February 28, 2022

Study Completion

October 31, 2022

Last Updated

August 31, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)