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Genistein Supplementation to Mitigate Cardiometabolic Dysfunction in Patients Undergoing Androgen Deprivation Therapy for Prostate Cancer

Status
Active
Cancer Type
Prostate Cancer
Trial Phase
Eligibility
18 and over, Male
Study Type
Prevention
Supportive care
NCD ID
NCT02766478
Protocol IDs
EU3129-15 (primary)
NCI-2016-00400
IRB00086186
Study Sponsor
Emory University/Winship Cancer Institute

Summary

This pilot randomized trial studies genistein in preventing or reducing diabetes (blood sugar), heart, or blood vessels disease (cardiometabolic dysfunction) in patients with prostate cancer undergoing androgen deprivation therapy. Androgen is a male hormone that binds to androgen receptors inside the cancer cells, which causes the cancer cells to grow. Antiandrogen therapy or androgen deprivation therapy prevents this from happening. Despite the benefits of antiandrogen therapy, it is associated with an increased risk of cardiovascular dysfunction, such as high blood sugar and/or high cholesterol. Genistein is a natural supplement that comes from soy that in studies has been shown to decrease blood glucose and cholesterol, and it may prevent or reduce cardiometabolic dysfunction in patients receiving androgen deprivation therapy.

Objectives

PRIMARY OBJECTIVES:

I. Assess indexes of insulin dynamics (insulin sensitivity and secretion) determined from an oral glucose tolerance test before and 12 weeks after a daily genistein or placebo supplement.

II. Assess measures of vascular function before and 12 weeks after a daily genistein or placebo supplement.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive genistein orally (PO) twice daily (BID) for 12 weeks.

GROUP II: Patients receive placebo PO BID for 12 weeks.

After completion of study, patients are followed up periodically.

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