Self Reported Pain in Women While Undergoing Treatment for Non-metastatic Breast Cancer
Part of paid clinical trials in Charlotte, North Carolina.
- Sponsor
- Wake Forest University Health Sciences
- Study ID
- NCT04174742
- Status
- Recruiting
Conditions
- Breast
- Breast Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- pegfilgrastim — DRUGIt 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.
Study Details
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 Dates
- Start date
- Dec 17, 2019
- Status verified
- May 2026
- Primary completion
- Jan 31, 2041
- Completion
- Jan 31, 2041
Study Design
- Enrollment
- 115 participants (estimated)
Arms
- Arm: ASubjects 45 years of age or younger
- Arm: BSubjects over 45 years of age
Primary Outcome Measure
Frequency of pain [ Time Frame: approx 7 months ]
Central Contacts
- Laura Moore, RN980-442-2340
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | Julie Fisher, MD (PRINCIPAL_INVESTIGATOR) |
| Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | Marissa Howard-McNatt, MD (PRINCIPAL_INVESTIGATOR) |
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