Clinical trial NCT02766478: Genistein Supplementation to Mitigate Cardiometabolic Dysfunction in Patients Undergoing Androgen Deprivation Therapy for Prostate Cancer
Official title: Genistein Supplementation to Mitigate Cardiometabolic Dysfunction in Patients Undergoing Androgen Deprivation Therapy for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2016-05-09
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Matsuda Index of Whole-Body Insulin Sensitivity at Baseline and Week 8 Post-baseline
timeFrame: Baseline, Week 8 post-baseline
measure: β-cell Insulin Secretion Capacity Assessed by the Insulinogenic Index at Baseline and Week 8 Post-baseline
timeFrame: Baseline, Week 8 post-baseline
Secondary outcomes:
measure: Arterial Stiffness
timeFrame: Baseline, Week 8
measure: Vascular Endothelial Function at Baseline and Week 8 Post-baseline
timeFrame: Baseline, Week 8 post-baseline
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Jessica Alvarez, PhD
role: PRINCIPAL_INVESTIGATOR
References: