Genistein in Preventing Cardiometabolic Dysfunction in Patients with Prostate Cancer Undergoing Androgen Deprivation Therapy
- Medical indication for androgen deprivation therapy (ADT) via luteinizing hormone-releasing hormone (LHRH) analog +/- oral anti-androgen
- Diagnosis of prostate cancer
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Life expectancy > 6 months
- Ability to provide informed consent
- Transmural myocardial infarction, unstable angina, or congestive heart failure requiring hospitalization within the last 6 months
- Acute coronary event within the past month
- Chronic liver disease
- Current use of cytotoxic or immunosuppressive drugs
- Chronic glucocorticoid or acute glucocorticoid or other synthetic steroid intake within the last month
- Chronic diarrhea or malabsorptive diseases (e.g., Crohn’s disease)
- Stage 5 chronic kidney disease or need for hemodialysis
- Supplemental oxygen dependency
- Brain metastasis
- Severe cognitive dysfunction impairing ability to provide informed consent or consume study drug
- Dysphagia or requirement for artificial feeding
- Surgery or hospitalization within the last month
- Chemotherapy or radiation therapy within the last 60 days
- Type 1 or type 2 diabetes
- Human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS)
- History (hx) of organ transplant
- ECOG performance status > 2
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.
Trial Phase Phase II
Trial Type Supportive care
Emory University Hospital / Winship Cancer Institute
- Primary ID EU3129-15
- Secondary IDs NCI-2016-00400, IRB00086186
- Clinicaltrials.gov ID NCT02766478