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

• Status: Suspended
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

Genistein is a natural supplement that comes from soy. The purpose of this study is to see if genistein has any effect on preventing or reducing heart disease and diabetes risk in men receiving Androgen Deprivation Therapy for prostate cancer. A combination of nutritional measures, blood markers and imaging tools will assess body composition, lipid levels and insulin resistance. Information from this pilot study will increase understanding of interventions which may prevent or reduce health risks during prostate cancer treatment. This project involves 24 men who will receive androgen deprivation therapy for prostate cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Androgens; Genistein

Criteria

Inclusion Criteria:

• Medical indication for androgen deprivation therapy (ADT) via luteinizing hormone-releasing hormone (LHRH) analog ± oral anti-androgen

• Diagnosis of prostate cancer

• ECOG performance status ≤ 2

• Life expectancy > 6 months

• Ability to provide informed consent

Exclusion Criteria:

• Transmural myocardial infarction, unstable angina, or congestive heart failure requiring hospitalization within the last 6 months

• Acute coronary event within the past month

• Use of intravenous antibiotics within the last 6 months

• 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

• Insulin dependent diabetes

• HIV/AIDS

• History of organ transplant

• ECOG performance status > 2