The overall purpose of this study is to investigate whether younger subjects report pain with pegfilgrastim (or biosimilar substitution) more often and/or at higher levels (greater intensity) than older subjects.This study will be carried out throughout the course of your chemotherapy treatment, which will be prescribed by your study doctor. Participation in this study will not affect your cancer treatment.
This study will measure pain using ESAS self-reported pain scores over the course of one week following each dose of pegfilgrastim (or biosimilar substitution). At the end of that week, blood will be drawn from each subject to directly measure the WBC/ANC, which can then be compared to self-reported pain and evaluated for any correlation. Finally, subjects will be divided into two groups by age: 45 years or younger, and over 45 to look for any differences in pain or WBC/ANC measurements based on age.
Study Type
OBSERVATIONAL
Enrollment
115
It works by increasing neutrophil migration to counteract cytotoxicity. It is commonly administered to patients receiving chemotherapy for breast cancer treatment. It has been shown to significantly reduce the incidence of neutropenic fever, although without statistically significant impact on overall survival.
Levine Cancer Institute
Charlotte, North Carolina, United States
RECRUITINGWake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
RECRUITINGFrequency of pain
investigate whether younger patients report pegfilgrastim (or biosimilar substitution)-induced pain with greater frequency than older patients.
Time frame: approx 7 months
Intensity of pain
investigate whether younger patients report pegfilgrastim (or biosimilar substitution)-induced pain at a higher intensity than older patients.
Time frame: approx 7 months
White Blood Cell/Absolute Neutrophil Count (WBC/ANC)
compare WBC/ANC count nadir between younger and older patients receiving pegfilgrastim (or biosimilar substitution).
Time frame: On day 7 of each pegfilgrastim or biosimilar substitution cycle (28 day cycle, approx 4-6 cycles) through study completion (one week after last administration of pegfilgrastim or biosimilar substitution)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.