Self Reported Pain in Women While Undergoing Treatment for Non-metastatic Breast Cancer
Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Nov 21, 2019
Trial Information
Current as of July 24, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how pain levels reported by women undergoing treatment for breast cancer might differ based on age. Specifically, the study will compare whether younger women (aged 18 and older) report more pain or more intense pain while receiving a medication called pegfilgrastim, which helps prevent low white blood cell counts during chemotherapy. If you decide to participate, it won't change how your cancer treatment is planned or delivered.
To be eligible for this study, you must be a woman aged 18 or older, diagnosed with invasive breast cancer, and scheduled to receive chemotherapy along with pegfilgrastim. You should also be able to read and understand English or Spanish. Participants will be asked to report their pain levels throughout their chemotherapy treatment, helping researchers understand the relationship between age and pain during this process. If you have certain medical conditions or a history of severe pain, you may not be able to join the study.
Gender
FEMALE
Eligibility criteria
- • 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.
About Wake Forest University Health Sciences
Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Charlotte, North Carolina, United States
Winston Salem, North Carolina, United States
Patients applied
Trial Officials
Julie Fisher, MD
Principal Investigator
Wake Forest University Health Sciences
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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