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Trial Title:
Correlation of Timing of Pegfilgrastim Administration and PIBP.
NCT ID:
NCT05841186
Condition:
Pegfilgrastim
Bone Pain
Chemotherapy
Breast Cancer
Patient-reported Outcomes
Quality of Life
Conditions: Keywords:
pegfilgrastim
bone pain
patient-reported outcomes
chemotherapy
Breast Cancer
health related-quality of life
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Timing of pegfilgrastim administration
Description:
Timing of pegfilgrastim administration
Arm group label:
24h group
Arm group label:
48h group
Arm group label:
72h group
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Breast Cancer, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences)
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Status:
Recruiting
Contact:
Last name:
Kun Wang, professor
Start date:
May 4, 2023
Completion date:
May 31, 2025
Lead sponsor:
Agency:
Guangdong Provincial People's Hospital
Agency class:
Other
Source:
Guangdong Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05841186
