RecruitingNot ApplicableNCT05841186

Correlation of Timing of Pegfilgrastim Administration and PIBP.

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


Sponsor

Guangdong Provincial People's Hospital

Enrollment

156 participants

Start Date

May 4, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether the timing of pegfilgrastim injections — a drug given to stimulate white blood cell production after chemotherapy — affects how much bone pain patients experience. Bone pain is a well-known side effect of this drug, and researchers want to see if adjusting the timing can reduce it. **You may be eligible if...** - You are 18 to 70 years old - You have a confirmed diagnosis of primary breast cancer - You are scheduled to receive chemotherapy and pegfilgrastim as part of your treatment - You are able to fill out questionnaires in Chinese - You do not have ongoing chronic pain from other conditions **You may NOT be eligible if...** - You already have bone pain from another disease - You are allergic to pegfilgrastim or your chemotherapy drugs - You have serious kidney, liver, or blood conditions that interfere with the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTiming of pegfilgrastim administration

Timing of pegfilgrastim administration


Locations(1)

Department of Breast Cancer, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences)

Guangzhou, Guangdong, China

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NCT05841186


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