Correlation of Timing of Pegfilgrastim Administration and PIBP.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-04

Study Completion Date

2025-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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24h group

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

Group Type OTHER

Timing of pegfilgrastim administration

Intervention Type OTHER

Timing of pegfilgrastim administration

48h group

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

Group Type OTHER

Timing of pegfilgrastim administration

Intervention Type OTHER

Timing of pegfilgrastim administration

72h group

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

Group Type OTHER

Timing of pegfilgrastim administration

Intervention Type OTHER

Timing of pegfilgrastim administration

Interventions

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Timing of pegfilgrastim administration

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No