Correlation of Timing of Pegfilgrastim Administration and PIBP(Pegfilgrastim-induced Bone Pain)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
24h group
Pegfilgrastim is administrated 24 hours after completing the chemotherapy in the 24-hour group.
Intervention: Timing of pegfilgrastim administration (Other)
48h group
Pegfilgrastim is administrated 48hours after completing the chemotherapy in the 48-hour group.
Intervention: Timing of pegfilgrastim administration (Other)
72h group
Pegfilgrastim is administrated 72 hours after completing the chemotherapy in the 72-hour group.
Intervention: Timing of pegfilgrastim administration (Other)
Outcomes
Primary Outcomes
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.
Time Frame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
Measured by Brief Pain Inventory-Short Form
Secondary Outcomes
- Incidence of bone pain(Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).)
- Incidence of severe bone pain(Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).)
- Duration of bone pain and severe bone pain(Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).)
- Impact of bone pain on daily life and other aspects.(Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).)
- Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Score.(Before pegfilgrastim administration in the first chemotherapy cycle (baseline), day 7 after each cycle of pegfilgrastim administration.)
- Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Breast Cancer-23 (EORTC QLQ-BR23) Score.(Before pegfilgrastim administration in the first chemotherapy cycle (baseline), day 7 after each cycle of pegfilgrastim administration.)
- Change From Baseline in European Quality of Life-Five Dimension-Five Level Scale (EQ-5D-5L) Score.(Before pegfilgrastim administration in the first chemotherapy cycle (baseline), day 7 after each cycle of pegfilgrastim administration.)
- Analgesic use(Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).)
- 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 every cycle.(Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).)
- Leukocyte count(Patients do blood routine tests on the seventh day of each chemotherapy cycle (Each cycle lasts 28 days, and day 1 denotes the day of chemotherapy completion) and when necessary.)
- Incidence of febrile neutropenia(Patients monitor their oral temperature daily, and do blood routine tests on the seventh day of each chemotherapy cycle (Each cycle lasts 28 days, and day 1 denotes the day of chemotherapy completion) and when necessary.)
- Incidence of neutropenia(Patients do blood routine tests on the seventh day of each chemotherapy cycle (Each cycle lasts 28 days, and day 1 denotes the day of chemotherapy completion) and when necessary.)
- Absolute neutrophil count(Patients do blood routine tests on the seventh day of each chemotherapy cycle (Each cycle lasts 28 days, and day 1 denotes the day of chemotherapy completion) and when necessary.)
Investigators
Kun Wang
professor
Guangdong Provincial People's Hospital