Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gary Morrow, University of Rochester
ClinicalTrials.gov Identifier:
NCT00602420
First received: January 22, 2008
Last updated: May 8, 2015
Last verified: May 2015
Results First Received: June 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Supportive Care
Conditions: Musculoskeletal Complications
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Interventions: Drug: naproxen
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
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  
Number of Participants  
[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  
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 [2]
[units: participants]
     
Breast     175     166     341  
Gynecologic     16     13     29  
Hematologic     18     17     35  
Lung     22     31     53  
Other     26     26     52  
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) [3]
[units: units on a scale]
Mean (Standard Deviation)
  1.78  (2.24)     1.87  (2.23)     1.83  (2.24)  
Bone pain today or during previous 3 days (scale, 0-10) [3]
[units: units on a scale]
Mean (Standard Deviation)
  0.47  (1.44)     0.64  (1.60)     0.56  (1.52)  
[1] 86% female, 14% male patients.
[2] 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.
[3] 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


No publications provided


Responsible Party: Gary Morrow, University of Rochester
ClinicalTrials.gov Identifier: NCT00602420     History of Changes
Other Study ID Numbers: CDR0000584341, U10CA037420, URCC-07079
Study First Received: January 22, 2008
Results First Received: June 24, 2014
Last Updated: May 8, 2015
Health Authority: United States: Federal Government