Investigating pain levels in younger vs older women during breast cancer treatment
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
This study is trying to see if younger women feel more pain than older women during chemotherapy for breast cancer while they receive a specific treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 115 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Charlotte, North Carolina and 1 other locations) |
| Trial ID | NCT04174742 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess pain levels reported by younger women compared to older women undergoing chemotherapy for non-metastatic breast cancer while receiving pegfilgrastim or its biosimilar. Participants will self-report their pain using the ESAS pain scores over a week following each dose of treatment. Blood samples will be collected to measure white blood cell counts, allowing for a comparison between self-reported pain and actual blood measurements. The study will categorize subjects into two age groups: 45 years or younger and over 45, to identify any differences in pain perception and blood count correlations based on age.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with invasive breast cancer undergoing chemotherapy and pegfilgrastim treatment.
Not a fit: Patients with uncontrolled medical or psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of pain management in breast cancer treatment, potentially leading to tailored therapies based on age.
How similar studies have performed: While similar studies have explored pain management in cancer treatment, this specific age-based comparison is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Charlotte, North Carolina and 1 other locations
- Levine Cancer Institute — Charlotte, North Carolina, United States (Recruiting)
- Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Julie Fisher, MD — Wake Forest University Health Sciences
- Study coordinator: Laura Moore, RN
- Email: laura.moore1@atriumhealth.org
- Phone: 980-442-2340
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.