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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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
North Carolina
Levine Cancer Institute
RECRUITING
Charlotte
Wake Forest Baptist Comprehensive Cancer Center
RECRUITING
Winston-salem
Contact Information
Primary
Laura Moore, RN
laura.moore1@atriumhealth.org
980-442-2340
Time Frame
Start Date: 2019-12-17
Estimated Completion Date: 2041-01
Participants
Target number of participants: 102
Treatments
A
Subjects 45 years of age or younger
B
Subjects over 45 years of age
Related Therapeutic Areas
Sponsors
Collaborators: Atrium Health Levine Cancer Institute
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov