Clinical trial NCT05841186: Correlation of Timing of Pegfilgrastim Administration and PIBP.
Official title: Correlation of Timing of Pegfilgrastim Administration and PIBP(Pegfilgrastim-induced Bone Pain)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pegfilgrastim
Bone Pain
Chemotherapy
Breast Cancer
Patient-reported Outcomes
Quality of Life
Keywords: pegfilgrastim
bone pain
patient-reported outcomes
chemotherapy
Breast Cancer
health related-quality of life
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
Secondary outcomes:
measure: Incidence of bone pain
timeFrame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
measure: Incidence of severe bone pain
timeFrame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
measure: Duration of bone pain and severe bone pain
timeFrame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
measure: Impact of bone pain on daily life and other aspects.
timeFrame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Score.
timeFrame: Before pegfilgrastim administration in the first chemotherapy cycle (baseline), day 7 after each cycle of pegfilgrastim administration.
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Breast Cancer-23 (EORTC QLQ-BR23) Score.
timeFrame: Before pegfilgrastim administration in the first chemotherapy cycle (baseline), day 7 after each cycle of pegfilgrastim administration.
measure: Change From Baseline in European Quality of Life-Five Dimension-Five Level Scale (EQ-5D-5L) Score.
timeFrame: Before pegfilgrastim administration in the first chemotherapy cycle (baseline), day 7 after each cycle of pegfilgrastim administration.
measure: Analgesic use
timeFrame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
measure: 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.
timeFrame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
measure: Leukocyte count
timeFrame: 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.
measure: Incidence of febrile neutropenia
timeFrame: 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.
measure: Incidence of neutropenia
timeFrame: 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.
measure: Absolute neutrophil count
timeFrame: 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.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Breast Cancer, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences)
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Kun Wang, professor
role: PRINCIPAL_INVESTIGATOR
References: