Actively Recruiting

Age: 18Years +
FEMALE
NCT04174742

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

Led by Wake Forest University Health Sciences · Updated on 2026-04-17

115

Participants Needed

2

Research Sites

1098 weeks

Total Duration

On this page

Sponsors

W

Wake Forest University Health Sciences

Lead Sponsor

A

Atrium Health Levine Cancer Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent and HIPAA authorization for release of personal health information
  • Age 18 years or older at the time of consent
  • Female
  • Histological or cytological confirmation of invasive breast cancer
  • Planned to undergo adjuvant or neoadjuvant chemotherapy treatment for invasive breast cancer AND pegfilgrastim (or biosimilar substitution) treatment for neutropenic prophylaxis
  • Ability to read and understand English and/or Spanish
  • Ability to understand and comply with study procedures for the entire length of the study as determined by the enrolling physician
Not Eligible

You will not qualify if you...

  • Uncontrolled illness or psychiatric/social conditions that would limit study compliance as determined by the investigator
  • Previously received chemotherapy or radiation other than the first cycle of planned chemotherapy
  • Taking chronic narcotics as determined by treating physician
  • Diagnosis of distant metastatic breast cancer
  • Diagnosis of a chronic pain syndrome (e.g. fibromyalgia, severe osteoarthritis)
  • Baseline ESAS pain score greater than 8

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Levine Cancer Institute

Charlotte, North Carolina, United States, 28204

Actively Recruiting

2

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

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Research Team

L

Laura Moore, RN

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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