This clinical trial tests a Mediterranean diet intervention to decrease risk of disease progression among men with prostate cancer that has not spread to other parts of the body (localized) at Lyndon B. Johnson (LBJ) Hospital. Low socioeconomic status is associated with prostate cancer death in men of all races and ethnicities. Therefore, identifying ways to delay disease progression in men with low socioeconomic status is important. Dietary interventions maybe a helpful way to modify the risk of prostate cancer progression and impact cardiovascular risk factors, given many men with localized prostate cancer will die of cardiovascular disease rather than prostate cancer. Previous research has shown that a Mediterranean diet, which is rich in fruits, vegetables, whole grains, and olive oil, may prevent damage to the heart and may be associated with decreased risk of prostate cancer progression in men whose disease is actively monitored. Using a Mediterranean diet intervention may decrease risk of prostate cancer progression and cardiovascular disease in men with localized prostate cancer at LBJ Hospital.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06935097.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Justin R. Gregg
Phone: 713-792-3250
Lyndon Baines Johnson General HospitalStatus: Active
Contact: Justin R. Gregg
Phone: 713-792-3250
PRIMARY OBJECTIVE:
I. To determine the feasibility of a Mediterranean diet-based intervention adapted for medically underserved men with prostate cancer.
SECONDARY OBJECTIVE:
I. To determine changes due to the Mediterranean diet intervention.
II. To determine fidelity of intervention, including a description of patient comprehension, cognitive skills and perceived ability to change diet during the intervention.
OUTLINE:
Patients receive a Mediterranean diet intervention over 8 weeks on study. The Mediterranean diet intervention includes the following: 1) Patients participate in a phone meeting with a dietitian for counseling and receive recipes and individually tailored recommendations for improving dietary quality to be consistent with Mediterranean diet patterns; 2) Patients participate in phone meetings with a dietitian to collect daily food diary data, receive continued counseling and motivation weekly on study; 3) Patients receive a supply of olive oil and walnuts at diet initiation and at 4 weeks on study, as well as fruits and vegetables and other food items from the food pharmacy prior to diet initiation and every 2 weeks while on study. Additionally, patients undergo blood sample collection throughout the study and may undergo tissue sample collection on study.
After completion of study intervention, patients are followed up at 6 months.
Trial PhaseNo phase specified
Trial Typebasic science
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorJustin R. Gregg
