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Effect of Soy on Cognition and Hot Flashes in Men With Prostate Cancer Undergoing Testosterone Suppression Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00245518
First Posted: October 28, 2005
Last Update Posted: October 13, 2017
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.
Collaborators:
Physicians Laboratories
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: August 14, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hot Flashes
Interventions: Drug: Isoflavone
Drug: Placebos

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
39 participants were enrolled in this study. 3 were not randomized due to failed screening on laboratory assessment, 2 because they withdrew due to personal reasons, and 1 because of dislike of the taste of the compound.

Reporting Groups
  Description
Isoflavone

Isoflavone

Isoflavone

Placebo Placebos

Participant Flow:   Overall Study
    Isoflavone   Placebo
STARTED   17   16 
COMPLETED   17   16 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline characteristics were only recorded for the 33 participants who completed the study.

Reporting Groups
  Description
Isoflavone

Isoflavone

Isoflavone

Placebo Placebos
Total Total of all reporting groups

Baseline Measures
   Isoflavone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   16   33 
Age, Customized 
[Units: Participants]
Count of Participants
     
>= 21 years   17   16   33 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      17 100.0%      16 100.0%      33 100.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   17   16   33 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cognitive Function as Assessed by the National Adult Reading Test (NART)   [ Time Frame: baseline, 6 weeks, 12 weeks ]

2.  Primary:   Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Total Recall Score   [ Time Frame: baseline, 6 weeks, 12 weeks ]

3.  Primary:   Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Recognition Discrimination Index   [ Time Frame: baseline, 6 weeks, 12 weeks ]

4.  Primary:   Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Percent Retained   [ Time Frame: baseline, 6 weeks, 12 weeks ]

5.  Primary:   Cognitive Function as Assessed by the F-A-S Test   [ Time Frame: baseline, 6 weeks, 12 weeks ]

6.  Primary:   Cognition as Assessed by the Grooved Pegboard Test (GPT) , Dominant Hand Time (Seconds)   [ Time Frame: baseline, 6 weeks, 12 weeks ]

7.  Primary:   Cognition as Assessed by the Grooved Pegboard Test (GPT) , Non-dominant Hand Time (Seconds)   [ Time Frame: baseline, 6 weeks, 12 weeks ]

8.  Primary:   Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Dominant Hand Drops   [ Time Frame: baseline, 6 weeks, 12 weeks ]

9.  Primary:   Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Non- Dominant Hand Drops   [ Time Frame: baseline, 6 weeks, 12 weeks ]

10.  Primary:   Cognition as Assessed by the Rex Complex Figure Test (RCFT), Immediate Recall   [ Time Frame: baseline, 6 weeks, 12 weeks ]

11.  Primary:   Cognition as Assessed by the Rex Complex Figure Test (RCFT), Delayed Recall   [ Time Frame: baseline, 6 weeks, 12 weeks ]

12.  Primary:   Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Total Score   [ Time Frame: baseline, 6 weeks, 12 weeks ]

13.  Primary:   Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Libido   [ Time Frame: baseline, 6 weeks, 12 weeks ]

14.  Primary:   Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Erectile Function   [ Time Frame: baseline, 6 weeks, 12 weeks ]

15.  Primary:   Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Arousal   [ Time Frame: baseline, 6 weeks, 12 weeks ]

16.  Primary:   Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Sanctification   [ Time Frame: baseline, 6 weeks, 12 weeks ]

17.  Primary:   Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Total Score   [ Time Frame: baseline, 6 weeks, 12 weeks ]

18.  Primary:   Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Erectile Function   [ Time Frame: baseline, 6 weeks, 12 weeks ]

19.  Primary:   Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Intercourse Satisfaction   [ Time Frame: baseline, 6 weeks, 12 weeks ]

20.  Primary:   Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Orgasmic Function   [ Time Frame: baseline, 6 weeks, 12 weeks ]

21.  Primary:   Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Sexual Desire   [ Time Frame: baseline, 6 weeks, 12 weeks ]

22.  Primary:   Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Overall Sexual Satisfaction   [ Time Frame: baseline, 6 weeks, 12 weeks ]

23.  Primary:   Daytime Sleepiness as Assessed by Epworth Sleepiness Scale (ESS)   [ Time Frame: baseline, 6 weeks, 12 weeks ]

24.  Primary:   Hot Flashes as Assessed by the Blatt-Kuppermann Index (Hot Flash Component)   [ Time Frame: baseline, 6 weeks, 12 weeks ]

25.  Primary:   Mental Health as Assessed by the Short Form 36 Questionnaire   [ Time Frame: baseline, 6 weeks, 12 weeks ]

26.  Primary:   Physical Health as Assessed by the Short Form 36 Questionnaire   [ Time Frame: baseline, 6 weeks, 12 weeks ]

27.  Primary:   Fatigue as Assessed by the Short Form 36 Questionnaire   [ Time Frame: baseline, 6 weeks, 12 weeks ]

28.  Primary:   Physical Functioning as Assessed by the Short Form 36 Questionnaire   [ Time Frame: baseline, 6 weeks, 12 weeks ]

29.  Primary:   Body Pain as Assessed by the Short Form 36 Questionnaire   [ Time Frame: baseline, 6 weeks, 12 weeks ]

30.  Primary:   General Health Perceptions as Assessed by the Short Form 36 Questionnaire   [ Time Frame: baseline, 6 weeks, 12 weeks ]

31.  Primary:   Role Limitations Due to Physical Health as Assessed by the Short Form 36 Questionnaire   [ Time Frame: baseline, 6 weeks, 12 weeks ]

32.  Primary:   Role Limitations Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire   [ Time Frame: baseline, 6 weeks, 12 weeks ]

33.  Primary:   Social Functioning Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire   [ Time Frame: baseline, 6 weeks, 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Johns Hopkins University Clinical Trials Program
Organization: Johns Hopkins University School of Medicine
phone: 410-550-6484
e-mail: registerclinicaltrials@jhmi.edu



Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00245518     History of Changes
Other Study ID Numbers: 04-08-09-04
First Submitted: October 26, 2005
First Posted: October 28, 2005
Results First Submitted: August 14, 2017
Results First Posted: October 13, 2017
Last Update Posted: October 13, 2017