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Correlation of Timing of Pegfilgrastim Administration and PIBP.

StatusUnknown
PhaseNot applicable
Started
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Record status
This record was last updated September 19, 2024 (before its estimated May 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Notable Primary endpoint revised
    • Start date: May 1, 2023 to May 4, 2023
    • Secondary endpoints revised (13)
    v3
  3. Notable Phase: Phase 2 to Not applicablev2 Show 7 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Enrollment target: 84 to 156
    • Primary endpoint revised
    • Study sites: 0 to 1
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints: 11 to 13
    • Study title shortened, about 5 words
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05841186
Lead Sponsor Guangdong Provincial People's Hospital
Conditions
(from sponsor)
Pegfilgrastim, Bone Pain, Chemotherapy, Breast Cancer, Patient-reported Outcomes, Quality of Life
Related terms Breast Neoplasms
Enrollment 156 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov