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

University of Arizona

Status: Unknown

Conditions: Prostate Cancer

Treatments: Behavioral: CLIPP2

Study type: Interventional

Funder types: Other

Identifiers

NCT04228055

1806697620-2

Details and patient eligibility

About

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.

Full 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

Enrollment: 36 estimated patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

CLIPP2

Experimental group

Description:

24 Week Lifestyle Modification Intervention

Treatment:

Behavioral: CLIPP2