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Pregabalin in Preventing Acute Pain Syndrome in Patients Receiving Paclitaxel

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ClinicalTrials.gov Identifier: NCT01637077
Recruitment Status : Completed
First Posted : July 10, 2012
Results First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Academic and Community Cancer Research United

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions: Pain
Peripheral Neuropathy
Interventions: Drug: pregabalin
Drug: placebo
Other: questionnaire administration

  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 (Pregabalin) Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Arm II (Placebo) Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.

Participant Flow:   Overall Study
    Arm I (Pregabalin)   Arm II (Placebo)
STARTED   23   23 
COMPLETED   19   22 
NOT COMPLETED   4   1 
Cancel                1                1 
Withdrawal by Subject                1                0 
No cycle 1 questionnaire data                2                0 



  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.
No text entered.

Reporting Groups
  Description
Arm I (Pregabalin) Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Arm II (Placebo) Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Total Total of all reporting groups

Baseline Measures
   Arm I (Pregabalin)   Arm II (Placebo)   Total 
Overall Participants Analyzed 
[Units: Participants]
 19   22   41 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.2  (12.9)   53.2  (14.3)   53.7  (13.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      19 100.0%      22 100.0%      41 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   19   22   41 


  Outcome Measures

1.  Primary:   Worst of the Pain Scores for the Week Following the First Cycle of Paclitaxel Administration, Paclitaxel-associated Acute Pain Syndrome (P-APS) Pain Score   [ Time Frame: From treatment initiation to 6 days following treatment initiation; up to 7 days ]

2.  Primary:   Maximum of the Average Pain Scores (Item 3, Appendix IV) Over the Period From Treatment Initiation to Day 7 (for Cycle 1).   [ Time Frame: From treatment initiation to 6 days following treatment initiation; up to 7 days ]

3.  Secondary:   Area Under the Curve Per Assessment (aAUCpa) of Worst, Average and Least Pain (Items 1-3 Appendix IV) for the First Cycle of Treatment.   [ Time Frame: From treatment initiation to 6 days following treatment initiation; up to 7 days ]

4.  Secondary:   Percentage of Participants With Grade 3 or Higher Adverse Events Considered At Least Possibly Related to Treatment   [ Time Frame: Baseline, day 8 prior to each paclitaxel course, and then every 30 days for 6 months after completion of study treatment ]

5.  Secondary:   The Percentage of Patients Who Use Non-prescription Pain Medications   [ Time Frame: From treatment initiation to 6 months. ]

6.  Secondary:   The Percentage of Patients Taking Opioid Medications   [ Time Frame: From treatment initiation to 6 months. ]

7.  Secondary:   The Percentage of Patients Who Report the Development of New Aches/Pains That They Attribute to Paclitaxel   [ Time Frame: From treatment initiation to 6 days following treatment initiation; up to 7 days ]

8.  Secondary:   The Worst Pain Reported at the End of the Week for the Overall Week (Item 2 Appendix V)   [ Time Frame: From treatment initiation to 6 days following treatment initiation; up to 7 days ]

9.  Secondary:   The Percentage of Patients Who Report, at Week’s End, Using Non-prescription Pain Medications   [ Time Frame: From treatment initiation to 6 days following treatment initiation; up to 7 days ]

10.  Secondary:   The Percentage of Patients Who Report, at Week’s End, Using Opioids   [ Time Frame: From treatment initiation to 6 days following treatment initiation; up to 7 days ]

11.  Secondary:   Area Under the Curve (AUC) of EORTC Sensory, Autonomic, and Motor Neuropathy Subscales   [ Time Frame: From treatment initiation to 6 months. ]


  Serious Adverse Events


  Other Adverse Events


  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
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  More Information

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: Charles L. Loprinzi, M.D.
Organization: Mayo Clinic
phone: 507/284-1623
e-mail: loprinzi.charles@mayo.edu



Responsible Party: Academic and Community Cancer Research United
ClinicalTrials.gov Identifier: NCT01637077     History of Changes
Obsolete Identifiers: NCT02166385
Other Study ID Numbers: RC11C3
NCI-2011-03646 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: March 9, 2012
First Posted: July 10, 2012
Results First Submitted: January 8, 2018
Results First Posted: April 6, 2018
Last Update Posted: April 6, 2018