Correlation of Timing of Pegfilgrastim Administration and PIBP(Pegfilgrastim-induced Bone Pain)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
Measured by Brief Pain Inventory-Short Form
次要结局
- 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.)
研究者
Kun Wang
professor
Guangdong Provincial People's Hospital