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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA012197 | U.S. NIH Grant/Contract | View source | |
| Pro00037721 | Other Identifier | Advarra IRB | |
| LCI-BRE-GCSF-001 | Other Identifier | Atrium Health |
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| Name | Class |
|---|---|
| Atrium Health Levine Cancer Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Subjects 45 years of age or younger |
| |
| B | Subjects over 45 years of age |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegfilgrastim | Drug | It works by increasing neutrophil migration to counteract cytotoxicity. It is commonly administered to patients receiving chemotherapy for breast cancer treatment. It has been shown to significantly reduce the incidence of neutropenic fever, although without statistically significant impact on overall survival. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of pain | investigate whether younger patients report pegfilgrastim (or biosimilar substitution)-induced pain with greater frequency than older patients. | approx 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of pain | investigate whether younger patients report pegfilgrastim (or biosimilar substitution)-induced pain at a higher intensity than older patients. | approx 7 months |
| White Blood Cell/Absolute Neutrophil Count (WBC/ANC) |
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Inclusion Criteria
Subject must meet all the following applicable inclusion criteria to participate in this study:
Exclusion Criteria
Subjects meeting any of the criteria below may not participate in the study:
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Female patients undergoing neoadjuvant or adjuvant chemotherapy for breast cancer who will receive pegfilgrastim (or biosimilar substitution) during their treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Moore, RN | Contact | 980-442-2340 | laura.moore1@atriumhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Julie Fisher, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Levine Cancer Institute | Recruiting | Charlotte | North Carolina | 28204 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C455861 | pegfilgrastim |
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|
compare WBC/ANC count nadir between younger and older patients receiving pegfilgrastim (or biosimilar substitution).
| 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) |
| Wake Forest Baptist Comprehensive Cancer Center | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |