Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy

University of Kansas

Status and phase: Terminated; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Placebo; Dietary Supplement: Flav-ein capsules

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00594620

9639

Details and patient eligibility

About

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

Full 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.

Enrollment: 11 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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11 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Subjects receive supplement

Treatment:

Dietary Supplement: Flav-ein capsules

2

Placebo Comparator group

Description:

Subjects will receive placebo

Treatment:

Drug: Placebo