Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00343382
First received: June 22, 2006
Last updated: September 24, 2014
Last verified: September 2014
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.
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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  
Number of Participants  
[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  
Study-Specific Measure  
[units: participants]
       
Yes     10     10     9     29  
No     54     54     56     164  
Unknown     0     1     1     2  
Study-Specific Measure  
[units: participants]
       
Yes     36     37     38     111  
No     28     27     27     82  
Unknown     0     1     1     2  
Study-Specific Measure  
[units: participants]
       
Mild     6     6     6     18  
Moderate     30     30     30     90  
Severe     28     29     30     87  
Study-Specific Measure  
[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:
Loprinzi CL, Balcueva EP, Liu H, et al.: A phase III randomized, double-blind, placebo-controlled study of pilocarpine for vaginal dryness: NCCTG study N04CA. [Abstract] J Clin Oncol 28 (Suppl15): A-9024, 2010.


Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00343382     History of Changes
Other Study ID Numbers: NCCTG-N04CA, NCI-2009-00648, CDR0000482969
Study First Received: June 22, 2006
Results First Received: July 16, 2014
Last Updated: September 24, 2014
Health Authority: United States: Food and Drug Administration