Clinical trial NCT04228055: Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer2 (CLIPP2)
Official title: Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer2 (CLIPP2)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Low Carbohydrate
Ketogenic
Androgen Deprivation Therapy
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
First posted: 2020-01-14
Enrollment: 36
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre and Post Study Model
Primary purpose: TREATMENT

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.

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

Eligibility 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%

Primary outcomes:
measure: Reach Recruiting Target
timeFrame: 6 Months
measure: Retention of Participants
timeFrame: 6 Months
measure: Adherence to Intervention
timeFrame: 6 Months
Secondary outcomes:
measure: Fasting Glucose
timeFrame: 6 Months
measure: Lipid Panel
timeFrame: 6 Months
measure: Hemoglobin A1c
timeFrame: 6 Months
measure: CBC
timeFrame: 6 Months
measure: CMP
timeFrame: 6 Months
measure: Global Quality of Life Questionnaire
timeFrame: 6 Months
measure: Specific Quality of Life Questionnaire
timeFrame: 6 Months
Other outcomes:
measure: Inflammatory Pathways Associated with Prostate Cancer
timeFrame: 6 Months
measure: Angiogenic Pathways Associated with Prostate Cancer
timeFrame: 6 Months
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Amit Algotar, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.