Clinical trial NCT00245518: Effect of Soy on Cognition and Hot Flashes in Men With Prostate Cancer Undergoing Testosterone Suppression Therapy
Official title: Effect of Isoflavones on Cognition, Quality of Life and Hot Flashes in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hot Flashes
Keywords: prostate cancer
soy
androgen deprivation
quality of life
isoflavones
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Physicians Laboratories
name: National Cancer Institute (NCI)
First posted: 2005-10-28
Enrollment: 39
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will look at the effects of a soy supplement called Revival on memory, quality of life, and hot flashes in men with prostate cancer who are being treated with testosterone suppression therapy. Hypothesis: Treating men who have prostate CA with daily Revival will result in at least a 50% reduction in hot flashes compared to placebo.

Detailed description: This research study will look at the effects of a soy supplement called Revival on memory, quality of life, and hot flashes in men with prostate cancer who are undergoing (ADT) androgen deprivation therapy. Participants will be given either placebo or Revival. Participants will be asked to take their supplement once/day for 14 weeks.Blood will be drawn to check on liver, kidney, thyroid, cholesterol,and prostate health. Urine will be collected to check on bone markers. Patients will be asked to complete questionnaires to test memory, attention span, and vocabulary.Possible benefits may include increase in memory, decrease in hot flashes, and a general increase in quality of life.

Eligibility criteria: Inclusion Criteria:

* men \> or =21 with prostate CA and hypogonadism for at least 3 months

Exclusion Criteria:

* on growth promoting agents
* on appetite stimulating agents
* on Prednisone and others

Primary outcomes:
measure: Cognitive Function as Assessed by the National Adult Reading Test (NART)
timeFrame: baseline, 6 weeks, 12 weeks
measure: Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Total Recall Score
timeFrame: baseline, 6 weeks, 12 weeks
measure: Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Recognition Discrimination Index
timeFrame: baseline, 6 weeks, 12 weeks
measure: Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Percent Retained
timeFrame: baseline, 6 weeks, 12 weeks
measure: Cognitive Function as Assessed by the F-A-S Test
timeFrame: baseline, 6 weeks, 12 weeks
measure: Cognition as Assessed by the Grooved Pegboard Test (GPT) , Dominant Hand Time (Seconds)
timeFrame: baseline, 6 weeks, 12 weeks
measure: Cognition as Assessed by the Grooved Pegboard Test (GPT) , Non-dominant Hand Time (Seconds)
timeFrame: baseline, 6 weeks, 12 weeks
measure: Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Dominant Hand Drops
timeFrame: baseline, 6 weeks, 12 weeks
measure: Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Non- Dominant Hand Drops
timeFrame: baseline, 6 weeks, 12 weeks
measure: Cognition as Assessed by the Rex Complex Figure Test (RCFT), Immediate Recall
timeFrame: baseline, 6 weeks, 12 weeks
measure: Cognition as Assessed by the Rex Complex Figure Test (RCFT), Delayed Recall
timeFrame: baseline, 6 weeks, 12 weeks
measure: Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Total Score
timeFrame: baseline, 6 weeks, 12 weeks
measure: Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Libido
timeFrame: baseline, 6 weeks, 12 weeks
measure: Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Erectile Function
timeFrame: baseline, 6 weeks, 12 weeks
measure: Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Arousal
timeFrame: baseline, 6 weeks, 12 weeks
measure: Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Sanctification
timeFrame: baseline, 6 weeks, 12 weeks
measure: Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Total Score
timeFrame: baseline, 6 weeks, 12 weeks
measure: Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Erectile Function
timeFrame: baseline, 6 weeks, 12 weeks
measure: Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Intercourse Satisfaction
timeFrame: baseline, 6 weeks, 12 weeks
measure: Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Orgasmic Function
timeFrame: baseline, 6 weeks, 12 weeks
measure: Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Sexual Desire
timeFrame: baseline, 6 weeks, 12 weeks
measure: Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Overall Sexual Satisfaction
timeFrame: baseline, 6 weeks, 12 weeks
measure: Daytime Sleepiness as Assessed by Epworth Sleepiness Scale (ESS)
timeFrame: baseline, 6 weeks, 12 weeks
measure: Hot Flashes as Assessed by the Blatt-Kuppermann Index (Hot Flash Component)
timeFrame: baseline, 6 weeks, 12 weeks
measure: Mental Health as Assessed by the Short Form 36 Questionnaire
timeFrame: baseline, 6 weeks, 12 weeks
measure: Physical Health as Assessed by the Short Form 36 Questionnaire
timeFrame: baseline, 6 weeks, 12 weeks
measure: Fatigue as Assessed by the Short Form 36 Questionnaire
timeFrame: baseline, 6 weeks, 12 weeks
measure: Physical Functioning as Assessed by the Short Form 36 Questionnaire
timeFrame: baseline, 6 weeks, 12 weeks
measure: Body Pain as Assessed by the Short Form 36 Questionnaire
timeFrame: baseline, 6 weeks, 12 weeks
measure: General Health Perceptions as Assessed by the Short Form 36 Questionnaire
timeFrame: baseline, 6 weeks, 12 weeks
measure: Role Limitations Due to Physical Health as Assessed by the Short Form 36 Questionnaire
timeFrame: baseline, 6 weeks, 12 weeks
measure: Role Limitations Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire
timeFrame: baseline, 6 weeks, 12 weeks
measure: Social Functioning Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire
timeFrame: baseline, 6 weeks, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University Clinical Trials Unit
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Shehzad Basaria, M.D.
role: PRINCIPAL_INVESTIGATOR
References: