At a glance
ClinicalIndex Comparison Record- ✓Age 18-70 years
- ✓Pathologically or histologically confirmed primary breast cancer
- ✓Able to receive scheduled chemotherapy regimen
- ✓Able to understand Chinese and complete questionnaires independently
- ✕Current bone pain from other diseases
- ✕Allergy or contraindication to chemotherapy or pegfilgrastim
- ✕Previous pegfilgrastim use
- ✕Prior chemotherapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05841186N/ARecruitingUpdate OverdueUpdated 21mo ago · Completion was 13mo agoCorrelation of Timing of Pegfilgrastim Administration and PIBP(Pegfilgrastim-induced Bone Pain)
In Brief
A clinical study evaluating Timing of pegfilgrastim administration for Pegfilgrastim and 5 related conditions. Currently recruiting, targeting 156 participants across 1 site.
Signals
Detailed Summary
According to the National Comprehensive Cancer Network (NCCN) guidelines, patients receiving high-risk or moderate-risk febrile neutropenia (FN) chemotherapy with at least one risk factor should receive prophylactic granulocyte colony-stimulating factors (G-CSFs). However, pegfilgrastim-induced bone pain (PIBP) remains a common and significant clinical issue without a satisfactory solution. Studies have reported that the incidence rate of PIBP is 71.3%, with severe bone pain occurring in 27.0% of cases. Currently, the available data on PIBP treatment are limited to case reports, reviews, and small randomized controlled trials. The NCCN guidelines recommend preventive oral non-steroidal anti-inflammatory drugs or antihistamines as the treatment for PIBP. However, even with these preventive measures, the incidence rate of PIBP remains high at 61.1%, with severe bone pain occurring in 19.2% of cases. Severe bone pain can significantly impact the patient's health-related quality of life (HRQol), leading to potential refusal of pegfilgrastim administration and subsequent dose reduction in effective chemotherapy. Ultimately, this may have negative implications for tumor cure rates and patient survival. Based on previous literature, it appears that delaying the administration of pegfilgrastim may be associated with a lower incidence of PIBP. Therefore, our study aims to investigate the correlation between the timing of pegfilgrastim administration and the occurrence of PIBP.
Study Details
Timeline
Interventions
Timing of pegfilgrastim administration