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Saw Palmetto: Symptom Management for Men During Radiation Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01585246
First Posted: April 25, 2012
Last Update Posted: August 11, 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.
Information provided by (Responsible Party):
Gwen Wyatt, Michigan State University
Results First Submitted: May 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Saw Palmetto
Drug: soybean oil soft gel

  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
No text entered.

Reporting Groups
  Description
Phase 1: Saw Palmetto Soft Gel 320mg/Day Participants in this arm received 320mg/day of Saw Palmetto Soft Gel capsules.
Phase 1: Saw Palmentto Soft Gel 640mg/Day Participants in this arm received 640mg/day of Saw Palmetto Soft Gel capsules.
Phase 1: Saw Palmetto Soft Gel 960mg/Day Participants in this arm received 960mg/day of Saw Palmetto Soft Gel capsules.
Phase 2: RCT Phase- Saw Palmetto Patients received the predetermine the maximum therapeutic dose of Saw Palmetto Soft Gel capsules in phase 1, which is 960mg.
Phase 2: RCT Phase- Placebo Patients received Soybean Oil Soft Gel as the placebo treatment

Participant Flow:   Overall Study
    Phase 1: Saw Palmetto Soft Gel 320mg/Day   Phase 1: Saw Palmentto Soft Gel 640mg/Day   Phase 1: Saw Palmetto Soft Gel 960mg/Day   Phase 2: RCT Phase- Saw Palmetto   Phase 2: RCT Phase- Placebo
STARTED   3   4   20   10   11 
COMPLETED   3   3   16   6   9 
NOT COMPLETED   0   1   4   4   2 
Lost to Follow-up                0                0                2                1                0 
Protocol Violation                0                0                0                0                1 
Withdrawal by Subject                0                0                1                2                1 
Other                0                1                1                1                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.
No text entered.

Reporting Groups
  Description
Phase 1: Saw Palmetto Soft Gel 320mg/Day Participants in this arm received 320mg/day of Saw Palmetto Soft Gel capsules.
Phase 1: Saw Palmetto Soft Gel 640mg/Day Participants in this arm received 640mg/day of Saw Palmetto Soft Gel capsules.
Phase 1: Saw Palmetto Soft Gel 960mg/Day Participants in this arm received 960mg/day of Saw Palmetto Soft Gel capsules.
Active Comparator: Phase 2: RCT Phase- Saw Palmetto Patients received the predetermine the maximum therapeutic dose of Saw Palmetto Soft Gel capsules in phase 1, which is 960mg
Placebo Comparator: Phase 2: RCT Phase- Placebo Patients received Soybean Oil Soft Gel as the placebo treatment
Total Total of all reporting groups

Baseline Measures
   Phase 1: Saw Palmetto Soft Gel 320mg/Day   Phase 1: Saw Palmetto Soft Gel 640mg/Day   Phase 1: Saw Palmetto Soft Gel 960mg/Day   Active Comparator: Phase 2: RCT Phase- Saw Palmetto   Placebo Comparator: Phase 2: RCT Phase- Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   4   20   10   11   48 
Age 
[Units: Years]
Mean (Standard Deviation)
 71  (3.0)   62.75  (12.09)   62.1  (5.3)   66.70  (11.30)   67.82  (7.22)   67.29  (9.16) 
Sex/Gender, Customized 
[Units: Participants]
           
Male   3   4   20   10   11   48 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
           
Hispanic or Latino      0   0.0%      0   0.0%      1   5.0%      0   0.0%      0   0.0%      1   2.1% 
Not Hispanic or Latino      3 100.0%      4 100.0%      14  70.0%      8  80.0%      8  72.7%      37  77.1% 
Unknown or Not Reported      0   0.0%      0   0.0%      5  25.0%      2  20.0%      3  27.3%      10  20.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
           
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      2  10.0%      1  10.0%      0   0.0%      3   6.3% 
White      3 100.0%      4 100.0%      15  75.0%      9  90.0%      10  90.9%      41  85.4% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      3  15.0%      0   0.0%      1   9.1%      4   8.3% 
Region of Enrollment 
[Units: Participants]
           
United States   3   4   20   10   11   48 


  Outcome Measures
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1.  Primary:   Feasibility   [ Time Frame: Baseline to Week 12 for each phase. ]

2.  Primary:   Efficacy   [ Time Frame: HRQOL: Baseline, week 12, 14, & 22. IPSS: Baseline, week 3-12, 14, & 22. ]

3.  Primary:   Number of Participants With Dose Limiting Toxicities to Determine the Maximum Tolerated Dose   [ Time Frame: Baseline to Week 12 ]


  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:  
Principal Investigators are NOT 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.


Results Point of Contact:  
Name/Title: Dr. Gwen Wyatt
Organization: Michigan State University
phone: 517-884-4630
e-mail: gwyatt@msu.edu



Responsible Party: Gwen Wyatt, Michigan State University
ClinicalTrials.gov Identifier: NCT01585246     History of Changes
Other Study ID Numbers: Application ID 213
First Submitted: April 23, 2012
First Posted: April 25, 2012
Results First Submitted: May 4, 2016
Results First Posted: July 14, 2017
Last Update Posted: August 11, 2017