Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05813145
Status:
COMPLETED
Last Update Posted:
2023-04-14
First Post:
2023-03-16
Brief Title:
Fenofibrate Role in Breast Cancer Patients
Sponsor:
Damanhour University
Organization:
Damanhour University
Study Overview
Official Title:
Fenofibrate Role Against Chemotherapy Induced Peripheral Neurotoxicity in Breast Cancer Patients
Status:
COMPLETED
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:
The aim of the study is to assess the efficacy of fenofibrate in either reversing andor preventing the development of PIPN in breast cancer patients treated with paclitaxel-based regimen The primary outcome clinical improvement of neuropathic pain and grade by 1-CT-CTCAE -VERSION-4 FACTGOG-NT-12 questionnaire and its effect on quality of life QOL
The secondary outcome the efficacy of fenofibrate in either reversing andor preventing the development of PIPN via alteration of either Nerve growth factor NGF or and NFL
The secondary outcome the efficacy of fenofibrate in either reversing andor preventing the development of PIPN via alteration of either Nerve growth factor NGF or and NFL
Detailed Description:
Ethical committee approval will be obtained from ethics committee of Faculty of Pharmacy Damanhur University
2 All participants should agree to take part in this clinical study and will provide informed consent
3 fifty female patients with diagnosed breast cancer who are candidates for will be recruited from Damanhur oncology center
4 All enrolled patients will be randomly assigned into two arms Group 1 Arm A n25 will receive four cycle of AC followed by paclitaxel 80 mgm2 weekly for 12 week
Group 2 Arm B n25 will receive the same regimen as group1 in addition to 160mg 17 18 fenofibrate once daily for 3 month
5 All patients will be submitted to
Full patient history and clinical examination
Routine follow up before and after each chemotherapy cycle complete blood picture liver function tests renal function tests
Serum samples will be collected from patients at the time of admission for measuring the neuropathy biomarkers Nerve growth factor NGF and NFL to lipid profile
Clinical assessment of neuropathic pain using FACTGOG NtX 12 questionnaire and NCT-CTCAE -VERSION-4
6 All patients will be followed up during paclitaxel treatment period 12 weeks At the end of paclitaxel treatment Serum samples will be collected from patients for measuring the biomarkers
7 Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results
8 Results conclusion discussion and recommendations will be given
2 All participants should agree to take part in this clinical study and will provide informed consent
3 fifty female patients with diagnosed breast cancer who are candidates for will be recruited from Damanhur oncology center
4 All enrolled patients will be randomly assigned into two arms Group 1 Arm A n25 will receive four cycle of AC followed by paclitaxel 80 mgm2 weekly for 12 week
Group 2 Arm B n25 will receive the same regimen as group1 in addition to 160mg 17 18 fenofibrate once daily for 3 month
5 All patients will be submitted to
Full patient history and clinical examination
Routine follow up before and after each chemotherapy cycle complete blood picture liver function tests renal function tests
Serum samples will be collected from patients at the time of admission for measuring the neuropathy biomarkers Nerve growth factor NGF and NFL to lipid profile
Clinical assessment of neuropathic pain using FACTGOG NtX 12 questionnaire and NCT-CTCAE -VERSION-4
6 All patients will be followed up during paclitaxel treatment period 12 weeks At the end of paclitaxel treatment Serum samples will be collected from patients for measuring the biomarkers
7 Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results
8 Results conclusion discussion and recommendations will be given
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