Phase 4 Completed N=33 Randomized Double-blind Treatment

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

Hot Flashes

Source: ClinicalTrials.gov NCT00245518 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2017

Primary outcomePrimary: Cognitive Function as Assessed by the National Adult Reading Test (NART) — 45.2; 39.6; 42.43; 41.29 units on a scale

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Cognitive Function as Assessed by the National Adult Reading Test (NART)	45.2; 39.6; 42.43; 41.29; 43.69; 41.57	—
PRIMARY Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Total Recall Score	24.67; 21.6; 24.87; 22.53; 25.85; 22.47	—
PRIMARY Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Recognition Discrimination Index	22.13; 20.8; 20.4; 21.47; 22.77; 22.67	—
PRIMARY Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Percent Retained	100.88; 89.82; 94.31; 94.08; 94.68; 95.21	—
PRIMARY Cognitive Function as Assessed by the F-A-S Test	58.79; 55.36; 64.47; 56.93; 63.31; 57.93	—
PRIMARY Cognition as Assessed by the Grooved Pegboard Test (GPT) , Dominant Hand Time (Seconds)	101.5; 91.8; 89.93; 78.73; 90.75; 83.8	—
PRIMARY Cognition as Assessed by the Grooved Pegboard Test (GPT) , Non-dominant Hand Time (Seconds)	115.43; 112.8; 98.86; 89.2; 102.73; 88.67	—
PRIMARY Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Dominant Hand Drops	0.64; 0.4; 0.14; 0.33; 0.09; 0.2	—
PRIMARY Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Non- Dominant Hand Drops	0.21; 0.6; 0.07; 0.4; 0.45; 0.27	—
PRIMARY Cognition as Assessed by the Rex Complex Figure Test (RCFT), Immediate Recall	20.87; 16.03; 24.33; 22.33; 25.92; 25.13	—
PRIMARY Cognition as Assessed by the Rex Complex Figure Test (RCFT), Delayed Recall	20.37; 23.07; 23.07; 20.43; 24.42; 24.27	—
PRIMARY Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Total Score	62.92; 62; 63.21; 63.83; 59.7; 67	—
PRIMARY Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Libido	22.21; 21.4; 22.13; 21.36; 21.42; 22.93	—
PRIMARY Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Erectile Function	26.83; 26; 26.29; 25.92; 25.36; 27.46	—
PRIMARY Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Arousal	3.92; 3.79; 4.36; 4.13; 3.45; 4.31	—
PRIMARY Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Sanctification	10.92; 10.69; 11; 11.92; 11.75; 12.5	—
PRIMARY Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Total Score	21.33; 11.31; 17.4; 13.2; 17.08; 15	—
PRIMARY Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Erectile Function	7.33; 3.27; 5.87; 3.67; 5.85; 4.53	—
PRIMARY Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Intercourse Satisfaction	3.8; 0.67; 2.33; 1.2; 2.15; 1.53	—
PRIMARY Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Orgasmic Function	1.73; 0.47; 1.27; 1.07; 1.46; 1.13	—
PRIMARY Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Sexual Desire	3.73; 2.8; 3.47; 3.07; 3.54; 2.93	—
PRIMARY Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Overall Sexual Satisfaction	4.73; 3.85; 4.47; 4.2; 4.08; 4.64	—
PRIMARY Daytime Sleepiness as Assessed by Epworth Sleepiness Scale (ESS)	7.07; 8.2; 7.2; 7.2; 7.31; 7.4	—
PRIMARY Hot Flashes as Assessed by the Blatt-Kuppermann Index (Hot Flash Component)	4.53; 7; 5; 6.43; 4.38; 7	—
PRIMARY Mental Health as Assessed by the Short Form 36 Questionnaire	81.23; 69.67; 77.37; 71.36; 80.66; 77.18	—
PRIMARY Physical Health as Assessed by the Short Form 36 Questionnaire	76.25; 64.25; 74.73; 65.75; 72.36; 66.92	—
PRIMARY Fatigue as Assessed by the Short Form 36 Questionnaire	64; 50.67; 63.67; 49.67; 67.69; 54	—
PRIMARY Physical Functioning as Assessed by the Short Form 36 Questionnaire	83.33; 71.67; 82.14; 71.33; 84.23; 78.33	—
PRIMARY Body Pain as Assessed by the Short Form 36 Questionnaire	78; 66; 74.33; 73; 76.35; 74	—
PRIMARY General Health Perceptions as Assessed by the Short Form 36 Questionnaire	63.37; 56; 65.67; 57; 61.54; 58.67	—
PRIMARY Role Limitations Due to Physical Health as Assessed by the Short Form 36 Questionnaire	80; 63.33; 71.67; 61.67; 67.31; 56.67	—
PRIMARY Role Limitations Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire	82.22; 68.89; 75.56; 75.56; 76.92; 80	—
PRIMARY Social Functioning Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire	94.17; 78.33; 83.33; 78.33; 89.42; 88.33	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00245518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.