Self Reported Pain in Women While Undergoing Treatment for Non-metastatic Breast Cancer
Self-Reported Pain and Nadir White Blood Cell/Absolute Neutrophil Count in Women 45 and Under Compared to Older Women Receiving Pegfilgrastim (or Biosimilar Substitution) While Undergoing Chemotherapy for Non-Metastatic Breast Cancer
Sponsor: Atrium Health Levine Cancer Institute
Listed as NCT04174742, this observational or N/A phase trial focuses on Breast and Breast Cancer and remains actively recruiting participants. Sponsored by Atrium Health Levine Cancer Institute, it has been updated 22 times since 2019, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)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.
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.
Status Flow
Change History
22 versions recorded-
Apr 18, 2026 — Present [daily]
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First recorded
Eligibility Summary
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.
Contact Information
- Atrium Health Levine Cancer Institute
- Wake Forest University Health Sciences
For direct contact, visit the study record on ClinicalTrials.gov .