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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02766478
Recruitment Status : Suspended (Enrollment and study activities are temporarily suspended due to COVID-19.)
First Posted : May 9, 2016
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Jessica Alvarez, Emory University

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Genistein Drug: Placebo Phase 2

Detailed Description:

This is a double-blind, randomized, placebo-controlled trial of daily oral genistein in 24 men initiating Androgen Deprivation Therapy (ADT) for prostate cancer (PCa). 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 ADT for PCa. A combination of nutritional measures, blood markers and imaging tools will assess body composition, lipid levels and insulin resistance. Information from this study will increase understanding of interventions which may prevent or reduce health risks during prostate cancer treatment.

All participants will receive standard counseling for diet and exercise by their oncology care team. Participants will be asked to withhold from any additional dietary supplements (with the exception of 1 standard daily multivitamin) during the study period. Participants will also be asked to complete a food diary for three days (on two weekdays and 1 weekend day).

Subjects will be randomized and stratified by diabetes status to either 60 mg/day oral genistein (30 mg taken twice daily), or matching placebo. The goal for randomizing based on diabetes status is to ensure approximately the same number of subjects who have diabetes and do not have diabetes receive genistein and placebo.

During follow-up, subjects will receive weekly reminders via phone call, text, or email to enhance compliance and monitor for potential adverse events. The 3-month study visit will be scheduled to coincide with the subject's standard of care follow-up visit. Three-month assessments will be the same as baseline assessments.

Investigators seek to 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. Measures of vascular function before and 12 weeks after a daily genistein or placebo supplement will also be assessed via ultrasound along with other metabolic measures via blood draw.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Genistein Supplementation to Mitigate Cardiometabolic Dysfunction in Patients Undergoing Androgen Deprivation Therapy for Prostate Cancer
Actual Study Start Date : October 16, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Genistein

Arm Intervention/treatment
Experimental: Genistein
Participants with and without diabetes will receive 60 mg/day oral genistein (30 mg taken twice daily) for 12 weeks.
Drug: Genistein
Genistein is a natural supplement that comes from soy. Genistein will be taken orally (30 mg twice daily) for 12 weeks.

Placebo Comparator: Placebo
Participants with and without diabetes will receive placebo taken twice daily for 12 weeks.
Drug: Placebo
A placebo pill will be taken orally for 12 weeks.




Primary Outcome Measures :
  1. Change in Matsuda Index of Whole-Body Insulin Sensitivity [ Time Frame: Baseline, Week 12 ]
    The Matsuda index is a measurement of insulin sensitivity from plasma glucose and insulin concentrations during the oral glucose tolerance test (OGTT).

  2. Change in β-cell Insulin Secretion Capacity assessed by the Insulinogenic Index [ Time Frame: Baseline, Week 12 ]
    β-cell insulin secretion will be assessed by the insulinogenic index by measuring the ratio of insulin to glucose.


Secondary Outcome Measures :
  1. Change in Arterial Stiffness [ Time Frame: Baseline, Week 12 ]
    Arterial stiffness will be assessed by applanation tonometry.

  2. Change in Vascular Endothelial Function [ Time Frame: Baseline, Week 12 ]
    Vascular endothelial function will be measured with flow-mediated dilation (FMD) via ultrasound.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766478


Locations
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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Jessica Alvarez, PhD Emory University
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Responsible Party: Jessica Alvarez, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT02766478    
Other Study ID Numbers: IRB00086186
First Posted: May 9, 2016    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Genistein
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists