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

NCT02766478 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB00086186
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Matsuda Index of Whole-Body Insulin Sensitivity at Baseline and Week 8 Post-baseline

  The Matsuda index is a measurement of insulin sensitivity from plasma glucose and insulin concentrations during the oral glucose tolerance test (OGTT). Insulin sensitivity was calculated at baseline and after 8 weeks with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\]. Higher values are reflective of better insulin sensitivity. This test is not used to clinically diagnose disease, and there is no accepted, standard cutoff to define impaired insulin sensitivity or insulin resistance based on this index.

  Baseline, Week 8 post-baseline

• β-cell Insulin Secretion Capacity Assessed by the Insulinogenic Index at Baseline and Week 8 Post-baseline

  β-cell insulin secretion was determined from the OGTT. It is calculated as the ratio of the change in insulin values over the first 30 minutes of the OGTT and the change in glucose values over the first 30 minutes. Higher values are reflective of higher insulin secretion. This test is not used to clinically diagnose disease, and there is no accepted, standard cutoff to define impaired insulin secretion based on this index.

  Baseline, Week 8 post-baseline

Secondary Outcomes (2)

• Arterial Stiffness

  Baseline, Week 8

• Vascular Endothelial Function at Baseline and Week 8 Post-baseline

  Baseline, Week 8 post-baseline

Study Arms (2)

Genistein

EXPERIMENTAL

Participants with and without diabetes will receive 60 mg/day oral genistein (30 mg taken twice daily) for 12 weeks.

Drug: Genistein

Placebo

PLACEBO COMPARATOR

Participants with and without diabetes will receive placebo taken twice daily for 12 weeks.

Drug: Placebo

Interventions

Genistein DRUG

Genistein is a natural supplement that comes from soy. Genistein will be taken orally (30 mg twice daily) for 12 weeks.

Genistein

Placebo DRUG

A placebo pill will be taken orally for 12 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Genistein

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Isoflavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Jessica Alvarez
• Organization: Emory University

jessica.alvarez@emory.edu

404-727-1390

Study Officials

• Jessica Alvarez, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 9, 2016
• Study Start: October 16, 2017
• Primary Completion: July 23, 2021
• Study Completion: July 23, 2021
• Last Updated: September 27, 2022
• Results First Posted: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)