Self Reported Pain in Women While Undergoing Treatment for Non-metastatic Breast Cancer

Recruiting

• Conditions: Breast
• Interventions: Drug: pegfilgrastim

• Registration Number: NCT04174742
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Detailed Description

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 Timeline

• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-22
• Study Start: 2019-12-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-23
• Primary Completion: 2041-01
• Study Completion: 2041-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	pegfilgrastim	Subjects 45 years of age or younger
B	pegfilgrastim	Subjects over 45 years of age

Primary Outcome Measures

Name	Time	Method
Frequency of pain	approx 7 months	investigate whether younger patients report pegfilgrastim (or biosimilar substitution)-induced pain with greater frequency than older patients.

Secondary Outcome Measures

Name	Time	Method
Intensity of pain	approx 7 months	investigate whether younger patients report pegfilgrastim (or biosimilar substitution)-induced pain at a higher intensity than older patients.
White Blood Cell/Absolute Neutrophil Count (WBC/ANC)	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)	compare WBC/ANC count nadir between younger and older patients receiving pegfilgrastim (or biosimilar substitution).

Trial Locations

Locations (1)

Levine Cancer Institute; 🇺🇸 Charlotte, North Carolina, United States