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

• Sponsor: University of Kansas Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00594620
• Collaborator: Amgen (Industry)
• Enrollment: 11
• Location: 1
• Arms: 2
• Duration (Months): 68
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Dietary Supplement: Flav-ein capsules; Drug: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Prospective Trial of Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy
• Study Start Date: Aug 1, 2004
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Subjects receive supplement	Dietary Supplement: Flav-ein capsules; Soy/isoflavone supplementation
Placebo Comparator: 2 Subjects will receive placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Efficacy of Using Isoflavones as Safer Alternative to Synthetic Estrogens [16 Weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

• University of Kansas Medical Center
• Amgen

Investigators

• Principal Investigator: Jeffrey M. Holzbeierlein, MD, University of Kansas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT00594620
• Other Study ID Numbers: 9639
• First Posted: Jan 15, 2008
• Last Update Posted: Feb 14, 2022
• Last Verified: Jan 1, 2022

• Additional relevant MeSH terms: Hot Flashes

Study Results

Participant Flow

Pre-assignment Detail	Study was terminated early due to low accrual. Study was blinded and no data was collected

Arm/Group Title	Arm 1/ Soy Supplementation	Arm 2/ Placebo
Arm/Group Description	Subjects receive supplement Flav-ein capsules: Soy/isoflavone supplementation	Subjects will receive placebo Placebo: Placebo
Period Title: Overall Study
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Arm 1/ Soy Supplementation	Arm 2/ Placebo	Total
Arm/Group Description	Subjects receive supplement Flav-ein capsules: Soy/isoflavone supplementation	Subjects will receive placebo Placebo: Placebo	Total of all reporting groups
Overall Participants	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male () []
Female
Male
Ethnicity (NIH/OMB) () []
Hispanic or Latino
Not Hispanic or Latino
Unknown or Not Reported

Outcome Measures

1. Primary Outcome

Title	Efficacy of Using Isoflavones as Safer Alternative to Synthetic Estrogens
Time Frame	16 Weeks

Outcome Measure Data

Analysis Population Description

The trial was stopped early due to failure to accrue Not enough subjects were enrolled with enough follow up to have data

Arm/Group Title	Flav-ein Capsules	Placebo
Arm/Group Description	Subjects receive supplement Flav-ein capsules: Soy/isoflavone supplementation	Subjects will receive placebo Placebo: Placebo
Measure Participants	0	0

Adverse Events

Arm/Group Title	Flav-ein Capsules		Placebo
Arm/Group Description	Subjects receive supplement Flav-ein capsules: Soy/isoflavone supplementation		Subjects will receive placebo Placebo: Placebo
All Cause Mortality
	Flav-ein Capsules		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Flav-ein Capsules		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Flav-ein Capsules		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)

Limitations/Caveats

Early termination due to low accrual. Insufficient number of participants for accurate analysis. No data collected.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.