Recruiting

Lifestyle Improvement

Sponsor:

University of Arizona

Code:

NCT04228055

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

CLIPP2

Study Details

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.

Conditions

Prostate Cancer

Study ID

NCT04228055

Start date

Aug 7, 2020

Status verified date

Aug, 2021

Completion date

Oct 31, 2022

Anticipated

Primary completion date

Feb 28, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

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%

Study Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CLIPP2

24 Week Lifestyle Modification Intervention

Interventions

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.

Primary outcome measure

  • Reach Recruiting Target [ Time Frame: 6 Months ]
  • Retention of Participants [ Time Frame: 6 Months ]
  • Adherence to Intervention [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Tracey Smith

5206268038traceysmith@email.arizona.edu

Amit Algotar, MD, PhD, MPH

5206268038algotar@email.arizona.edu

Locations

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Tracey Smith

520-626-8038traceysmith@arizona.edu

More Information

Sponsor

University of Arizona

Last update posted

Aug 31, 2021

Last verified

Aug, 2021

Keywords

  • Low Carbohydrate
  • Ketogenic
  • Androgen Deprivation Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Arizona on 2021-08-31.