Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05841186
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2023-04-07
Brief Title:
Correlation of Timing of Pegfilgrastim Administration and PIBP
Sponsor:
Guangdong Provincial Peoples Hospital
Organization:
Guangdong Provincial Peoples Hospital
Study Overview
Official Title:
Correlation of Timing of Pegfilgrastim Administration and PIBPPegfilgrastim-induced Bone Pain
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 713 with severe bone pain occurring in 270 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 611 with severe bone pain occurring in 192 of cases Severe bone pain can significantly impact the patients 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
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 611 with severe bone pain occurring in 192 of cases Severe bone pain can significantly impact the patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None