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Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00343382
First received: June 22, 2006
Last updated: July 12, 2016
Last verified: July 2016
Results First Received: July 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Supportive Care
Conditions: Breast Cancer
Vaginal Dryness
Interventions: Drug: pilocarpine hydrochloride
Other: placebo

  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
Two-hundred and one (201) participants were recruited between December 2006 and May 2009 from 22 North Central Cancer Treatment Group (NCCTG) member sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Five participants (2 collective placebo, 2 Pilocarpine 2 times per day, 1 Pilocarpine 4 times per day) canceled prior to study medication begins and one Pilocarpine 2 times per day participant was ineligible. These six participants were excluded from all analysis.

Reporting Groups
  Description
Collective Placebo Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
Pilocarpine 2 Times Per Day Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
Pilocarpine 4 Times Per Day Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.

Participant Flow:   Overall Study
    Collective Placebo   Pilocarpine 2 Times Per Day   Pilocarpine 4 Times Per Day
STARTED   64   65   66 
COMPLETED   60   51   49 
NOT COMPLETED   4   14   17 
Adverse Event                2                10                7 
Withdrawal by Subject                1                2                6 
Other Reason Not Specified                1                2                4 



  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
Collective Placebo Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
Pilocarpine 2 Times Per Day Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
Pilocarpine 4 Times Per Day Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
Total Total of all reporting groups

Baseline Measures
   Collective Placebo   Pilocarpine 2 Times Per Day   Pilocarpine 4 Times Per Day   Total 
Overall Participants Analyzed 
[Units: Participants]
 64   65   66   195 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.6  (7.93)   55.1  (8.14)   54.7  (7.25)   54.8  (7.74) 
Gender, Customized 
[Units: Participants]
       
Female   64   65   66   195 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   1   0   1   2 
Asian   0   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   3   1   0   4 
White   60   63   65   188 
More than one race   0   0   0   0 
Unknown or Not Reported   0   1   0   1 
Region of Enrollment 
[Units: Participants]
       
United States   64   65   66   195 
Tamoxifen use 
[Units: Participants]
       
Yes   10   10   9   29 
No   54   54   56   164 
Unknown   0   1   1   2 
Current aromatase inhibitor 
[Units: Participants]
       
Yes   36   37   38   111 
No   28   27   27   82 
Unknown   0   1   1   2 
Severity of vaginal symptoms 
[Units: Participants]
       
Mild   6   6   6   18 
Moderate   30   30   30   90 
Severe   28   29   30   87 
Breast cancer history 
[Units: Participants]
       
Yes   55   59   58   172 
No   9   6   8   23 


  Outcome Measures
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1.  Primary:   Average Vaginal Dryness Scores Via Area Under the Curve (AUC) Summary Statistics   [ Time Frame: Baseline to Week 6 ]

2.  Secondary:   Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 3.0   [ Time Frame: End of 6 weeks ]

3.  Secondary:   Average AUC Summary Statistics for the Impact of Vaginal Dryness for Activities of Daily Living   [ Time Frame: Baseline to Week 6 ]

4.  Secondary:   Change From Baseline to Week 6 on the Impact of Vaginal Dryness for Activities of Daily Living Scores   [ Time Frame: Baseline and Week 6 ]


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


Results Point of Contact:  
Name/Title: Dr. Charles L. Loprinzi
Organization: Mayo Clinic
phone: 507-284-1623
e-mail: cloprinzi@mayo.edu


Publications of Results:

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00343382     History of Changes
Other Study ID Numbers: NCCTG-N04CA
NCI-2009-00648 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000482969 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: June 22, 2006
Results First Received: July 16, 2014
Last Updated: July 12, 2016
Health Authority: United States: Food and Drug Administration