Correlation of Timing of Pegfilgrastim Administration and PIBP.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorGuangdong Provincial People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Suffering from bone pain due to other diseases currently.
Allergy or contraindication to chemotherapeutic agents or pegfilgrastim.
Previous use of pegfilgrastim.
Previous received chemotherapy.
Trial design
Design model
Parallel
Treatments tested in this trial
Timing of pegfilgrastim administration
Other interventionTiming of pegfilgrastim administration
Treatment groups
156 Participants
are divided into 3 treatment groupsGroup A: 24h groupOther 1 intervention
Group B: 48h groupOther 1 intervention
Group C: 72h groupOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Measured by Brief Pain Inventory-Short Form
Time frame
Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).Secondary outcomes
1
Incidence of bone pain
Measured by Brief Pain Inventory-Short Form
Time frame
Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).2
Incidence of severe bone pain
Measured by Brief Pain Inventory-Short Form
Time frame
Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).3
Duration of bone pain and severe bone pain
Measured by Brief Pain Inventory-Short Form
Time frame
Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).4
Impact of bone pain on daily life and other aspects.
Measured by Brief Pain Inventory-Short Form
Time frame
Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).Sponsors and contacts
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Source ClinicalTrials.gov