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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

Tracking Information
First Submitted Date  ICMJE May 6, 2016
First Posted Date  ICMJE May 9, 2016
Last Update Posted Date May 29, 2020
Actual Study Start Date  ICMJE October 16, 2017
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2016)
  • 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).
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2016)
  • Change in Arterial Stiffness [ Time Frame: Baseline, Week 12 ]
    Arterial stiffness will be assessed by applanation tonometry.
  • Change in Vascular Endothelial Function [ Time Frame: Baseline, Week 12 ]
    Vascular endothelial function will be measured with flow-mediated dilation (FMD) via ultrasound.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Genistein Supplementation to Mitigate Cardiometabolic Dysfunction in Patients Undergoing Androgen Deprivation Therapy for Prostate Cancer
Official Title  ICMJE Genistein Supplementation to Mitigate Cardiometabolic Dysfunction in Patients Undergoing Androgen Deprivation Therapy for Prostate Cancer
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Genistein
    Genistein is a natural supplement that comes from soy. Genistein will be taken orally (30 mg twice daily) for 12 weeks.
  • Drug: Placebo
    A placebo pill will be taken orally for 12 weeks.
Study Arms  ICMJE
  • Experimental: Genistein
    Participants with and without diabetes will receive 60 mg/day oral genistein (30 mg taken twice daily) for 12 weeks.
    Intervention: Drug: Genistein
  • Placebo Comparator: Placebo
    Participants with and without diabetes will receive placebo taken twice daily for 12 weeks.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: May 6, 2016)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02766478
Other Study ID Numbers  ICMJE IRB00086186
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jessica Alvarez, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jessica Alvarez, PhD Emory University
PRS Account Emory University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP