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Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gary Morrow, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier:
NCT00602420
First received: January 22, 2008
Last updated: October 13, 2015
Last verified: October 2015
Results First Received: June 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Supportive Care
Conditions: Musculoskeletal Complications
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Interventions: Drug: naproxen
Other: placebo

  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
Naproxen

Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.

naproxen: Oral naproxen twice daily for 5-8 days.

Placebo

Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.

placebo: Oral placebo twice daily for 5-8 days.


Participant Flow:   Overall Study
    Naproxen   Placebo
STARTED   257   253 
COMPLETED   232   229 
NOT COMPLETED   25   24 
Death                1                4 
Chemotoxicity, Inc. Data,Ineligible                5                3 
Withdrawal by Subject                18                17 
Adverse Event                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.
At least 145 evaluable patients in each treatment group, thus 290 evaluable patients in total, required for an 80% power analysis.

Reporting Groups
  Description
Naproxen

Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.

naproxen: Oral naproxen twice daily for 5-8 days.

Placebo

Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.

placebo: Oral placebo twice daily for 5-8 days.

Total Total of all reporting groups

Baseline Measures
   Naproxen   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 257   253   510 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.6  (12.8)   56.8  (11.1)   56.2  (12.0) 
Gender [1] 
[Units: Participants]
     
Female   222   215   437 
Male   35   38   73 
[1] 86% female, 14% male patients.
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   8   6   14 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   14   19   33 
White   228   227   455 
More than one race   0   0   0 
Unknown or Not Reported   7   1   8 
Region of Enrollment 
[Units: Participants]
     
United States   257   253   510 
Tumor Type [1] 
[Units: Participants]
     
Breast   175   166   341 
Gynecologic   16   13   29 
Hematologic   18   17   35 
Lung   22   31   53 
Other   26   26   52 
[1] Patients required to have diagnosis of nonmyeloid cancer and were approached for study participation before first dose of pegfilgrastim on day 2, 3, or 4 of chemotherapy cycle.
Marital Status 
[Units: Participants]
     
Married   181   179   360 
Not Married   72   72   144 
Unknown   4   2   6 
Education 
[Units: Participants]
     
Some college   180   164   344 
High school or less   73   87   160 
Other   4   2   6 
Previous tamoxifen 
[Units: Participants]
     
Yes   8   11   19 
No   245   240   485 
Unknown   4   2   6 
Previous chemotherapy 
[Units: Participants]
     
Yes   60   75   135 
No   193   176   369 
Unknown   4   2   6 
Previous Radiation Therapy 
[Units: Participants]
     
Yes   18   30   48 
No   235   221   456 
Unknown   4   2   6 
Pain at its worst in last 24 hours (scale, 0-10) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 1.78  (2.24)   1.87  (2.23)   1.83  (2.24) 
[1] Any rating of bone pain from 1 to 10 was considered a day with pain. "No pain" is an instance in which patients scored their pain 0, and "any pain" for all other responses. Severe pain was similarly defined as any bone pain score greater than 5.
Bone pain today or during previous 3 days (scale, 0-10) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 0.47  (1.44)   0.64  (1.60)   0.56  (1.52) 
[1] Any rating of bone pain from 1 to 10 was considered a day with pain. "No pain" is an instance in which patients scored their pain 0, and "any pain" for all other responses. Severe pain was similarly defined as any bone pain score greater than 5.


  Outcome Measures

1.  Primary:   Area Under Curve (AUC) of Average Pain From Diary vs. Day (1-5), Calculated by the Trapezoidal Rule.   [ Time Frame: From baseline through day 5 ]


  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: Charles E. Heckler, PhD, MS. Research Assistant Professor
Organization: University of Rochester Medical Center
phone: 585-273-1141
e-mail: checkler@urmc.rochester.edu



Responsible Party: Gary Morrow, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier: NCT00602420     History of Changes
Other Study ID Numbers: CDR0000584341
U10CA037420 ( U.S. NIH Grant/Contract )
URCC-07079 ( Other Identifier: URCC )
Study First Received: January 22, 2008
Results First Received: June 24, 2014
Last Updated: October 13, 2015