Correlation of Timing of Pegfilgrastim Administration and PIBP.

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Enrolling

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

Treatments: Other: Timing of pegfilgrastim administration

Study type: Interventional

Funder types: Other

Identifiers

NCT05841186

KY-Q-2022-474-02

Details and patient eligibility

About

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.

Enrollment: 156 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 3 patient groups

24h group

Other group

Description:

Pegfilgrastim is administrated 24 hours after completing the chemotherapy in the 24-hour group.

Treatment:

Other: Timing of pegfilgrastim administration

48h group

Other group

Description:

Pegfilgrastim is administrated 48hours after completing the chemotherapy in the 48-hour group.

Treatment:

Other: Timing of pegfilgrastim administration

72h group

Other group

Description:

Pegfilgrastim is administrated 72 hours after completing the chemotherapy in the 72-hour group.

Treatment:

Other: Timing of pegfilgrastim administration