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

Breast Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04174742
• Other study ID #: IRB00081356
• Secondary ID: Pro00037721LCI-B
• Status: Recruiting
• Start date: December 17, 2019
• Est. completion date: January 2041

Study information

• Verified date: January 2024
• Source: Wake Forest University Health Sciences
• Contact: Laura Moore, RN
• Phone: 980-442-2340
• Email: laura.moore1[@]atriumhealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: January 2041
• Est. primary completion date: January 2041
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Subject must meet all the following applicable inclusion criteria to participate in this study:

1. 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.

2. Age = 18 years at the time of consent

3. Female

4. Histological or cytological confirmation of invasive breast cancer.

5. Planned to undergo adjuvant or neoadjuvant chemotherapy treatment for invasive breast cancer AND pegfilgrastim (or biosimilar substitution) treatment for neutropenic prophylaxis.

6. Ability to read and understand the English and/or Spanish language

7. As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study

Exclusion Criteria

Subjects meeting any of the criteria below may not participate in the study:

1. Uncontrolled intercurrent illness/medical condition or psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator

2. Have previously received chemotherapy or radiation other than the first cycle of the planned adjuvant or neoadjuvant chemotherapy as indicated in Inclusion #5

3. Taking chronic narcotics, as determined by treating physician

4. Diagnosis of distant metastatic breast cancer

5. Diagnosis of a chronic pain syndrome (e.g. fibromyalgia, severe osteoarthritis, etc.)

6. A baseline ESAS pain score of greater than 8.

Related Conditions & MeSH terms

• Breast

Intervention

Drug:
• pegfilgrastim
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.

Locations

Country	Name	City	State
United States	Levine Cancer Institute	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Atrium Health Levine Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of pain	investigate whether younger patients report pegfilgrastim (or biosimilar substitution)-induced pain with greater frequency than older patients.	approx 7 months
Secondary	Intensity of pain	investigate whether younger patients report pegfilgrastim (or biosimilar substitution)-induced pain at a higher intensity than older patients.	approx 7 months
Secondary	White Blood Cell/Absolute Neutrophil Count (WBC/ANC)	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)