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Spots Global Cancer Trial Database for Self Reported Pain in Women While Undergoing Treatment for Non-metastatic Breast Cancer

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We do not endorse or review these studies in any way.

Trial Identification

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

Official Title: 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

Study ID: NCT04174742

Conditions

Breast

Interventions

pegfilgrastim

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Levine Cancer Institute, Charlotte, North Carolina, United States

Contact Details

Name: Julie Fisher, MD

Affiliation: Wake Forest University Health Sciences

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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