Prostate Cancer
Conditions
Brief summary
To determine the efficacy of soy/isoflavone supplementation on hot flashes in men who are being treated with luteinizing hormone-releasing hormone (LHRH) agonist therapy for control of advanced prostate cancer
Detailed description
Literature has shown that low dose estrogens can control hot flashes in men on androgen deprivation but with a high risk of thromboembolic events. Soy derivatives that contain isoflavones, a type of phytoestrogen, have been evaluated in peri-menopausal women as a possible safer alternative to synthetic estrogens but there has not been a similar study performed on their effect in men on androgen deprivation therapy for prostate cancer.
Interventions
DIETARY_SUPPLEMENTFlav-ein capsules
Soy/isoflavone supplementation
DRUGPlacebo
Placebo
Sponsors
Amgen
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically proven adenocarcinoma of prostate with treatment of prostate cancer (radical prostatectomy, radiation therapy, etc.) * had biochemical/clinical relapse and started on antiandrogens * have documented history of hot flashes
Exclusion criteria
* History of MI, DVT, CVA * peanut allergy * untreated hypothyroidism * must be off other medical treatment for hot flashes for 2 weeks before enrollment in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of Using Isoflavones as Safer Alternative to Synthetic Estrogens | 16 Weeks |
Countries
United States
Participant flow
Pre-assignment details
Study was terminated early due to low accrual. Study was blinded and no data was collected
Participants by arm
| Arm | Count |
|---|---|
| Arm 1/ Soy Supplementation Subjects receive supplement
Flav-ein capsules: Soy/isoflavone supplementation | 0 |
| Arm 2/ Placebo Subjects will receive placebo
Placebo: Placebo | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
Efficacy of Using Isoflavones as Safer Alternative to Synthetic Estrogens
Time frame: 16 Weeks
Population: The trial was stopped early due to failure to accrue Not enough subjects were enrolled with enough follow up to have data