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Recruiting NCT05841186

Correlation of Timing of Pegfilgrastim Administration and PIBP.

No phase Interventional Pegfilgrastim Bone Pain Chemotherapy Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Timing of pegfilgrastim administration.
Who it may be relevant to
Registry conditions: Pegfilgrastim, Bone Pain, Chemotherapy, Breast Cancer. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Correlation of Timing of Pegfilgrastim Administration and PIBP(Pegfilgrastim-induced Bone Pain)

Overview

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.

Interventions

  • Other Timing of pegfilgrastim administration
    Timing of pegfilgrastim administration

Primary outcome measures

  • The area under the curve (AUC) for daily worst bone pain score for days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration) in cycle 1. [Time frame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).]
Secondary outcome measures (12)
  • Incidence of bone pain [Time frame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).]
  • Incidence of severe bone pain [Time frame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).]
  • Duration of bone pain and severe bone pain [Time frame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).]
  • Impact of bone pain on daily life and other aspects. [Time frame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).]
  • Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Score. [Time frame: Before pegfilgrastim administration in the first chemotherapy cycle (baseline), day 7 after each cycle of pegfilgrastim administration.]
  • Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Breast Cancer-23 (EORTC QLQ-BR23) Score. [Time frame: Before pegfilgrastim administration in the first chemotherapy cycle (baseline), day 7 after each cycle of pegfilgrastim administration.]
  • Change From Baseline in European Quality of Life-Five Dimension-Five Level Scale (EQ-5D-5L) Score. [Time frame: Before pegfilgrastim administration in the first chemotherapy cycle (baseline), day 7 after each cycle of pegfilgrastim administration.]
  • Analgesic use [Time frame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).]
  • The area under the curve (AUC) for daily worst bone pain score for days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration) in every cycle. [Time frame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).]
  • Leukocyte count [Time frame: Patients do blood routine tests on the seventh day of each chemotherapy cycle (Each cycle lasts 28 days, and day 1 denotes the day of chemotherapy completion) and when necessary.]
  • Incidence of febrile neutropenia [Time frame: Patients monitor their oral temperature daily, and do blood routine tests on the seventh day of each chemotherapy cycle (Each cycle lasts 28 days, and day 1 denotes the day of chemotherapy completion) and when necessary.]
  • Incidence of neutropenia [Time frame: Patients do blood routine tests on the seventh day of each chemotherapy cycle (Each cycle lasts 28 days, and day 1 denotes the day of chemotherapy completion) and when necessary.]

Eligibility criteria

Inclusion criteria

  • Age greater than or equal to 18 years and less than or equal to 70 years.
  • Pathologically or histologically confirmed diagnosis of primary breast cancer.
  • Able to receive the chemotherapy regimen as scheduled.
  • Able to understand Chinese and fill out the study-related questionnaires independently.
  • Given written informed consent.
  • There is no need to use prescription or over-the-counter drugs regularly because of pre-existing chronic pain.

Exclusion criteria

  • Suffering from bone pain due to other diseases currently.
  • Allergy or contraindication to chemotherapeutic agents or pegfilgrastim.
  • Previous use of pegfilgrastim.
  • Previous received chemotherapy.
  • Pregnancy or breastfeeding.
  • Concurrently accompanied by other primary malignant tumors.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Breast Cancer, Guangdong Provincial People's Hospital (Guangdong Academy of — Guangzhou

Publications

  • Li P, Chen Y, Lin Y, Zhang X, Cheng M, Zhu T, Gao HF, Zhang L, Li J, Huang N, Chen Y, Liang M, Zhang Y, Huang S, Zheng J, Wu C, Yang C, Wang K. Timing of Pegfilgrastim Administration and Pegfilgrastim-Induced Bone Pain : A Prospective, Randomized, Phase 3 Trial. Ann Intern Med. 2026 May;179(5):656-665. doi: 10.7326/ANNALS-25-02600. Epub 2026 Mar 24. PMID 41871353

Identifiers

NCT: NCT05841186 · KY-Q-2022-474-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗