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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
  Purpose
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.

Condition Intervention Phase
Hot Flashes Drug: Isoflavone Drug: Placebos Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Isoflavones on Cognition, Quality of Life and Hot Flashes in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Cognitive Function as Assessed by the National Adult Reading Test (NART) [ Time Frame: baseline, 6 weeks, 12 weeks ]
    the NART estimates intelligence levels of English-speaking patients. It consists of 50 short words with irregular spelling or phonetic appearance which the participant must read and pronounce. The higher the score, the higher number of correct responses. Scores are 0-50.

  • Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Total Recall Score [ Time Frame: baseline, 6 weeks, 12 weeks ]
    The test consists 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. Approximately 20-25 min later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, & 6 semantically unrelated. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score ( -12) ; the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition.

  • Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Recognition Discrimination Index [ Time Frame: baseline, 6 weeks, 12 weeks ]
    The test consists 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. Approximately 20-25 min later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, & 6 semantically unrelated. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score ( -12) ; the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score= higher cognitive function.

  • Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Percent Retained [ Time Frame: baseline, 6 weeks, 12 weeks ]
    The test consists 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. Approximately 20-25 min later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, and 6 semantically unrelated. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score ( -12) ; the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives.A higher score= higher cognitive function.

  • Cognitive Function as Assessed by the F-A-S Test [ Time Frame: baseline, 6 weeks, 12 weeks ]
    The F-A-S Test, a subtest of the Neurosensory Center Comprehensive Examination for Aphasia (NCCEA), is a measure of phonemic word fluency, which is a type of verbal fluency. It assesses phonemic fluency by requesting an individual to orally produce as many words as possible that begin with the letters F, A, and S within a prescribed time frame (1 minute)

  • Cognition as Assessed by the Grooved Pegboard Test (GPT) , Dominant Hand Time (Seconds) [ Time Frame: baseline, 6 weeks, 12 weeks ]
    The GPT assesses eye-hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole. A faster time, indicates greater cognitive functioning.

  • Cognition as Assessed by the Grooved Pegboard Test (GPT) , Non-dominant Hand Time (Seconds) [ Time Frame: baseline, 6 weeks, 12 weeks ]
    The GPT assesses eye-hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the non-dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole.

  • Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Dominant Hand Drops [ Time Frame: baseline, 6 weeks, 12 weeks ]
    The GPT assesses eye-hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole.

  • Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Non- Dominant Hand Drops [ Time Frame: baseline, 6 weeks, 12 weeks ]
    The GPT assesses eye-hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole.

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

    The test measures recognition memory for the elements of the Rey complex figure, and assesses the respondent's ability to use cues to retrieve information. Scoring of drawings is based on the widely used 36-point scoring system. Each of the 18 scoring units is scored based on accuracy and placement criteria. Items of the figure can earn points:

    1. Correct Image: placed properly (2 points), placed poorly (1 point)
    2. Distorted or Incomplete Image, but recognizable: placed properly (1 point), placed poorly (1/2) point
    3. Absent or not recognizable: 0 points

    Scale ranges 0-36. with 36 being greatest cognitive function.


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

    The test measures recognition memory for the elements of the Rey complex figure, and assesses the respondent's ability to use cues to retrieve information after 25-30 minutes. Scoring of drawings is based on the widely used 36-point scoring system. Each of the 18 scoring units is scored based on accuracy and placement criteria. Items of the figure can earn points:

    1. Correct Image: placed properly (2 points), placed poorly (1 point)
    2. Distorted or Incomplete Image, but recognizable: placed properly (1 point), placed poorly (1/2) point
    3. Absent or not recognizable: 0 points

    Scale ranges 0-36, with 36 representing maximum cognition .


  • Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Total Score [ Time Frame: baseline, 6 weeks, 12 weeks ]
    The WSFQ contains 17 items that assess the domains of sexual desire/libido (6 items), arousal (1 item), orgasm/erectile function (7 items), and satisfaction(3 items). A five-point Likert-type scale ranging from "always" to "never" is used to generate a total score and four domain scores. The possible range of total sexual function scores is 17 to 85. Higher scores indicate better sexual function.

  • Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Libido [ Time Frame: baseline, 6 weeks, 12 weeks ]
    The domain of sexual desire/libido consists of 6 items. A five-point Likert-type scale ranging from "always" to "never" is used to generate a score, ranging from 6-30. Higher scores indicate increased libido/sexual desire.

  • Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Erectile Function [ Time Frame: baseline, 6 weeks, 12 weeks ]
    The domain of erectile function/orgasm consists of 7 items. A five-point Likert-type scale ranging from "always" to "never" is used to generate a score, ranging from 7-35. Higher scores indicate increased erectile function/achievement of orgasm.

  • Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Arousal [ Time Frame: baseline, 6 weeks, 12 weeks ]
    The domains of arousal (1 item subscale of the WSFQ), is assessed using a five-point Likert-type scale ranging from "always" to "never" to generate the score for arousal. The higher the number (range 1-5), the more the participant is able to experience arousal.

  • Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Sanctification [ Time Frame: baseline, 6 weeks, 12 weeks ]
    The domains of satisfaction (3 items), is assessed using a five-point Likert-type scale ranging from "always" to "never" to generate the score, ranging from 3-15. The higher the number, the higher the level of satisfaction with sexual function.

  • Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Total Score [ Time Frame: baseline, 6 weeks, 12 weeks ]
    IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions which refer to the past 4 weeks only. The questions are split into the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The total score ranges from 6-75 with 6 being minimal erectile function and 75 representing maximal erectile function.

  • Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Erectile Function [ Time Frame: baseline, 6 weeks, 12 weeks ]
    IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. Erectile function is one domain, making up 6 out of 15 questions. The score ranges from 1-30, with the lowest score representing minimal erectile function.

  • Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Intercourse Satisfaction [ Time Frame: baseline, 6 weeks, 12 weeks ]
    IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being satisfaction with intercourse. A score of 0-5 is awarded to each of the 3 questions which refer to the past 4 weeks only. The score rangers from 0-15, with a score of 0 indicating that no intercourse was attempted in the last 4 weeks, 1= almost or little to no sanctification, 15= very highly satisfied.

  • Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Orgasmic Function [ Time Frame: baseline, 6 weeks, 12 weeks ]
    IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being satisfaction with orgasm. A score of 0-5 is awarded to each of the 2 questions which refer to the past 4 weeks only. The score rangers from 1-10, with a score of 0 indicating that no sexual stimulation or intercourse was attempted in the last 4 weeks, 1= almost never or never ejaculated, 10= almost always or always

  • Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Sexual Desire [ Time Frame: baseline, 6 weeks, 12 weeks ]
    IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being sexual desire. A score of 0-5 is awarded to each of the 2 questions which refer to the past 4 weeks only. The score rangers from 2-10, with a score of 2 indicating very low or none at all, and 10 representing almost always/very high.

  • Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Overall Sexual Satisfaction [ Time Frame: baseline, 6 weeks, 12 weeks ]
    IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being sexual satisfaction. A score of 0-5 is awarded to each of the 2 questions which refer to the past 4 weeks only. The score rangers from 2-10, with a score of 2 indicating very dissatisfied and 10 being very satisfied.

  • Daytime Sleepiness as Assessed by Epworth Sleepiness Scale (ESS) [ Time Frame: baseline, 6 weeks, 12 weeks ]
    The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.

  • Hot Flashes as Assessed by the Blatt-Kuppermann Index (Hot Flash Component) [ Time Frame: baseline, 6 weeks, 12 weeks ]
    Hot flashes were assessed using symptom severity 0= none, slight=1, moderate=2, and severe = 3. Hot flashes have a weighting factor of 4 on the overall Blatt-Kuppermann index, making score ranges 0-12, with 12 being the most severe hot flashes.

  • Mental Health as Assessed by the Short Form 36 Questionnaire [ Time Frame: baseline, 6 weeks, 12 weeks ]
    The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health

  • Physical Health as Assessed by the Short Form 36 Questionnaire [ Time Frame: baseline, 6 weeks, 12 weeks ]
    The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health

  • Fatigue as Assessed by the Short Form 36 Questionnaire [ Time Frame: baseline, 6 weeks, 12 weeks ]
    The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health

  • Physical Functioning as Assessed by the Short Form 36 Questionnaire [ Time Frame: baseline, 6 weeks, 12 weeks ]
    The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health

  • Body Pain as Assessed by the Short Form 36 Questionnaire [ Time Frame: baseline, 6 weeks, 12 weeks ]
    The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health

  • General Health Perceptions as Assessed by the Short Form 36 Questionnaire [ Time Frame: baseline, 6 weeks, 12 weeks ]
    The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health

  • Role Limitations Due to Physical Health as Assessed by the Short Form 36 Questionnaire [ Time Frame: baseline, 6 weeks, 12 weeks ]
    The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health

  • Role Limitations Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire [ Time Frame: baseline, 6 weeks, 12 weeks ]
    The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health

  • Social Functioning Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire [ Time Frame: baseline, 6 weeks, 12 weeks ]
    The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health


Enrollment: 39
Study Start Date: June 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Isoflavone
Isoflavone
Drug: Isoflavone
Placebo Comparator: Placebo Drug: Placebos

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245518


Locations
United States, Maryland
Johns Hopkins University Clinical Trials Unit
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Physicians Laboratories
National Cancer Institute (NCI)
Investigators
Principal Investigator: Shehzad Basaria, M.D. Johns Hopkins University
  More Information

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
Last Verified: September 2017

Keywords provided by Johns Hopkins University:
prostate cancer
soy
androgen deprivation
quality of life
isoflavones

Additional relevant MeSH terms:
Prostatic Neoplasms
Hot Flashes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Signs and Symptoms
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs