Correlation of Timing of Pegfilgrastim Administration and PIBP.

Recruiting now · Not applicable

Conditions studied: Pegfilgrastim, Bone Pain, Chemotherapy, Breast Cancer, Patient-reported Outcomes, Quality of Life

In brief

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.

Key facts

Study ID

NCT05841186

Run by

Guangdong Provincial People's Hospital

People needed

156

Starts

2023-05-04

Expected to finish

2025-05-31

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Department of Breast Cancer, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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