Health TrialsbyHealthPanel

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

ConditionsBreastBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Female

Histological or cytological confirmation of invasive breast cancer.

Disqualifiers

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

Trial population

Female patients undergoing neoadjuvant or adjuvant chemotherapy for breast cancer who will receive pegfilgrastim (or biosimilar substitution) during their treatment.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • pegfilgrastim

    Drug

    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.

Treatment groups

115 Participants
are divided into 2 treatment groups
Group A: A1 intervention
Group B: B1 intervention

Trial outcomes

Primary outcomes

1

Frequency of pain

investigate whether younger patients report pegfilgrastim (or biosimilar substitution)-induced pain with greater frequency than older patients.

Time frame
approx 7 months

Secondary outcomes

1

Intensity of pain

investigate whether younger patients report pegfilgrastim (or biosimilar substitution)-induced pain at a higher intensity than older patients.

Time frame
approx 7 months
2

White Blood Cell/Absolute Neutrophil Count (WBC/ANC)

compare WBC/ANC count nadir between younger and older patients receiving pegfilgrastim (or biosimilar substitution).

Time frame
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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

Atrium Health Levine Cancer Institute

Collaborator

Source ClinicalTrials.gov
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