Clinical trial NCT06682390: Role of Race in Nutritional Approach in Men on ADT
Official title: Contribution of Race to Nutritional Approach to Lower Cardiovascular Risk Factors in Men Undergoing Androgen Deprivation Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer Metastatic Disease
Keywords: ADT
cardiovascular risk factors
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Comprehensive Cancer Network
First posted: 2024-11-12
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: There is a well-documented association between androgen deprivation therapy (ADT) and cardiovascular morbidity. A majority of men on ADT gain weight contributing to an increase in cardiovascular risk factors (CVRFs) and cardiovascular morbidity. Dietary intervention combined with exercise have shown success in reducing weight/fat mass and improving cardiovascular risk factors (CVRF). There is little data on whether African American men would respond to diet and exercise interventions differently from non-Hispanic white men. We will conduct a pilot, controlled two-phase intervention study stratified by race to investigate the following objectives:

1. Compare effect of a hypocaloric, anti-inflammatory diet on changes in fat mass between African- American vs non-Hispanic white men with metastatic prostate cancer on ADT therapy.
2. Compare effect of a hypocaloric, anti-inflammatory diet on changes in cardiovascular risk factors (body weight, lean body mass, waist-to-height ratio, blood pressure, lipids and HbA1C) and inflammatory markers (hs-CRP and cytokines) between African-American vs non-Hispanic white men with metastatic prostate cancer on ADT therapy.
3. Compare effect of a hypocaloric, anti-inflammatory diet on changes in cancer-related fatigue and quality of life between African-American vs non-Hispanic white men with metastatic prostate cancer on ADT therapy.

We will enroll 35 African American and 35 non-Hispanic white men with prostate cancer undergoing ADT therapy. In phase 1, after baseline assessment, men will consume their habitual diet and continue their habitual activity level for 3 months. During phase 2, participants will be instructed to consume a hypocaloric (-500 kcal), anti- inflammatory diet and walk for 1 hour on 3 days per week for 3 months. At baseline, after phase 1 and 2 primary outcome (fat mass) and secondary outcomes (CVRF and inflammatory markers) and tertiary outcomes (cancer-related fatigue and quality of life) will be determined.


Eligibility criteria: Inclusion Criteria:

* \>12 months on ADT
* Expected continuation of ADT for \>6 months upon initiation of study procedures
* Serum testosterone \<50 ng/dL
* BMI \>25
* Age \>18 years old
* African American and Non-Hispanic white males
* Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent

Exclusion Criteria:

* Life expectancy \< 1 year
* Females
* Radiation or chemotherapy treatment
* History of diabetes or serious medical condition including uncontrolled hypertension, liver, kidney, and cardiovascular disease
* Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator
* Any subject who currently uses tobacco products
* Any use of \>20 g of alcohol per day
* Any subject who is unable or unwilling to comply with the study protocol
* Any subject who is unable to provide consent

Primary outcomes:
measure: Fat mass
timeFrame: At baseline, 3 months and 6 months
measure: Waist circumference
timeFrame: At baseline, 3 months and 6 months
Secondary outcomes:
measure: Blood lipids and lipoproteins (triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol)
timeFrame: At baseline, 3 months and 6 months
measure: HbA1c
timeFrame: At baseline, 3 months and 6 months
measure: Total testosterone
timeFrame: At baseline, 3 months and 6 months
measure: Inflammatory markers (hs-CRP, IL-6, IL-1b, TNFa)
timeFrame: At baseline, 3 months and 6 months
measure: Serum free fatty acids
timeFrame: At baseline, 3 months and 6 months
measure: Diet and physical activity
timeFrame: At baseline, 3 months and 6 months
Other outcomes:
measure: Cancer-related fatigue
timeFrame: At baseline, 3 months and 6 months
measure: Quality of life
timeFrame: At baseline, 3 months and 6 months
Locations:
city: Los Angeles
country: United States
facility: Greater Los Angeles Division of Veterans Affairs
state: California
city: Los Angeles
country: United States
facility: UCLA Health 200 Medical Plaza
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Zhaoping Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Greater Los Angeles Division of Veterans Affairs, Los Angeles, California 90073
name: Matthew Rettig, MD
role: PRINCIPAL_INVESTIGATOR
References: