Self Reported Pain in Women While Undergoing Treatment for Non-metastatic Breast Cancer
Running, not enrolling
Conditions studied: Breast, Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT04174742
- Run by
- Wake Forest University Health Sciences
- People needed
- 115
- Starts
- 2019-12-17
- Expected to finish
- 2041-01-01
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Subject must meet all the following applicable inclusion criteria to participate in this study:
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years 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 the English and/or Spanish language
- As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study
You may not qualify if…
- Subjects meeting any of the criteria below may not participate in the study:
- Uncontrolled intercurrent illness/medical condition or psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator
- Have previously received chemotherapy or radiation other than the first cycle of the planned adjuvant or neoadjuvant chemotherapy as indicated in Inclusion #5
- 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, etc.)
- A baseline ESAS pain score of greater than 8.
Where it is running
- Levine Cancer Institute — Charlotte, North Carolina, United States
- Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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