Correlation of Timing of Pegfilgrastim Administration and Pegfilgrastim-induced Bone Pain in Breast Cancer Patients

What this Trial Is About

Researchers are investigating the timing of pegfilgrastim administration and its relationship to pegfilgrastim-induced bone pain (PIBP) in patients with breast cancer receiving chemotherapy classified as high or moderate risk for febrile neutropenia. PIBP is a common and significant problem affecting quality of life and treatment adherence, with current preventive treatments including oral non-steroidal anti-inflammatory drugs or antihistamines showing limited effectiveness. The study aims to clarify whether delaying pegfilgrastim administration reduces the incidence and severity of PIBP. Participants are randomly assigned to one of three groups receiving pegfilgrastim 24, 48, or 72 hours after completing chemotherapy. The study compares these timing schedules to observe differences in bone pain occurrence. Pegfilgrastim administration timing is the primary intervention being evaluated, with no masking or blinding. The trial is sponsored by Guangdong Provincial People's Hospital. Throughout the study, participants will report daily worst bone pain scores for five days after pegfilgrastim administration in each chemotherapy cycle. Researchers will assess the incidence, duration, and severity of bone pain and its impact on daily life and quality of life using several questionnaires. Blood tests will monitor leukocyte and neutrophil counts, and febrile neutropenia incidence will be tracked. The study continues through multiple chemotherapy cycles, with data collected at baseline and follow-up points to evaluate outcomes and safety over the treatment period.

Correlation of Timing of Pegfilgrastim Administration and PIBP.