We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

L-Arginine Supplementation With or Without Enzyme Inhibitors Treating Erectile Function of Prostate Cancer Survivors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01105130
First Posted: April 16, 2010
Last Update Posted: June 20, 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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
Results First Submitted: January 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions: Male Erectile Disorder
Prostate Cancer
Radiation Toxicity
Interventions: Other: Placebo
Dietary Supplement: Oral L-Arginine

  Participant Flow
  Hide Participant Flow

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
Arm I - Placebo

Patients receive oral placebo twice daily (total of 6 capsules per day).

Placebo: Given orally

Arm II - Low Dose

Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).

Placebo: Given orally

Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules

Arm III - High Dose

Oral L-arginine twice daily = 6 capsules per day.

Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules

Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily


Participant Flow:   Overall Study
    Arm I - Placebo   Arm II - Low Dose   Arm III - High Dose
STARTED   48   45   47 
COMPLETED   38   34   37 
NOT COMPLETED   10   11   10 
Withdrawal by Subject                4                6                2 
Never Started                2                2                4 
Toxicity                1                3                2 
Multiple Reasons                3                0                2 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
All randomized participants

Reporting Groups
  Description
Arm I - Placebo

Patients receive oral placebo twice daily (total of 6 capsules per day).

Placebo: Given orally

Arm II - Low Dose

Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).

Placebo: Given orally

Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules

Arm III - High Dose

Oral L-arginine twice daily = 6 capsules per day.

Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules

Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily

Total Total of all reporting groups

Baseline Measures
   Arm I - Placebo   Arm II - Low Dose   Arm III - High Dose   Total 
Overall Participants Analyzed 
[Units: Participants]
 48   45   47   140 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      14  29.2%      13  28.9%      13  27.7%      40  28.6% 
>=65 years      34  70.8%      32  71.1%      34  72.3%      100  71.4% 
Age 
[Units: Years]
Median (Full Range)
 68 
 (48 to 78) 
 68 
 (54 to 80) 
 67 
 (53 to 80) 
 68 
 (48 to 80) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Male      48 100.0%      45 100.0%      47 100.0%      140 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      1   2.1%      1   2.2%      0   0.0%      2   1.4% 
Not Hispanic or Latino      45  93.8%      43  95.6%      45  95.7%      133  95.0% 
Unknown or Not Reported      2   4.2%      1   2.2%      2   4.3%      5   3.6% 
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% 
Asian      0   0.0%      0   0.0%      2   4.3%      2   1.4% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      13  27.1%      17  37.8%      17  36.2%      47  33.6% 
White      35  72.9%      28  62.2%      28  59.6%      91  65.0% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
       
United States   48   45   47   140 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Erectile Function   [ Time Frame: 8 weeks ]

2.  Secondary:   Retention   [ Time Frame: 8 weeks ]

3.  Secondary:   Adherence   [ Time Frame: 8 weeks ]

4.  Secondary:   Quality of Life   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Doug Case
Organization: Wake Forest NCORP Research Base
phone: (336) 716-1048
e-mail: dcase@wakehealth.edu



Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01105130     History of Changes
Other Study ID Numbers: REBACCCWFU 98110
U10CA081851 ( U.S. NIH Grant/Contract )
First Submitted: April 14, 2010
First Posted: April 16, 2010
Results First Submitted: January 12, 2015
Results First Posted: July 21, 2015
Last Update Posted: June 20, 2017