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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 115
- 试验地点
- 4
- 主要终点
- Frequency of pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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.
研究组 & 干预措施
A
Subjects 45 years of age or younger
干预措施: pegfilgrastim (Drug)
B
Subjects over 45 years of age
干预措施: pegfilgrastim (Drug)
结局指标
主要结局
Frequency of pain
时间窗: approx 7 months
investigate whether younger patients report pegfilgrastim (or biosimilar substitution)-induced pain with greater frequency than older patients.
次要结局
- Intensity of pain(approx 7 months)
- White Blood Cell/Absolute Neutrophil Count (WBC/ANC)(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))