search
Back to results

Fenofibrate Role in Breast Cancer Patients

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Placebo
Fenofibrate 160mg
Sponsored by
Damanhour University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria: included a diagnosis breast cancer with age > 18 years. Naïve to chemotherapy Exclusion Criteria: Concurrent administration (statins , cyclosporine) . Advanced liver disease (defined as liver enzyme elevation >3-fold upper limit of normality, or cirrhosis); chronic kidney disease (CKD, defined as an eGFR <60 ml min-1 1.73 m-2); acute or chronic pancreatitis and diabetes. Patients with a history of allergy to fenofibrate. Concomitant use of opioids, anticonvulsants, tricyclic antidepressants, other neuropathic pain medication. Pregnancy or breast feeding.

Sites / Locations

  • Damanhour Oncology CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo Group

fenofibrate group

Arm Description

n=25: will receive Placebo plus four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week.

n=25: will receive fenofibrate 160mg once daily for 3 month plus four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week. .

Outcomes

Primary Outcome Measures

Nerve growth factor (NGF) Concentration
Concentration of Nerve growth factor (NGF)
Neurofilament light chain (NfL) protein Concentration
Concentration of Neurofilament light chain (NfL) protein

Secondary Outcome Measures

Incidence of neuropathic pain
neuropathic pain using score from FACT/GOG NtX 12 questionnaire .

Full Information

First Posted
March 16, 2023
Last Updated
April 1, 2023
Sponsor
Damanhour University
search

1. Study Identification

Unique Protocol Identification Number
NCT05813145
Brief Title
Fenofibrate Role in Breast Cancer Patients
Official Title
Fenofibrate Role Against Chemotherapy Induced Peripheral Neurotoxicity in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Damanhour University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the study is to assess the efficacy of fenofibrate in either reversing and/or 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 & FACT/GOG-NT-12 questionnaire and its effect on quality of life (QOL). The secondary outcome : the efficacy of fenofibrate in either reversing and/or 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) (n=25: will receive four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week. Group 2 ( Arm B) (n=25): 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 FACT/GOG 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1 ( Arm A) (n=25: will receive four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week. Group 2 ( Arm B) (n=25): will receive the same regimen as group1 in addition to 160mg (17 ,18 ) fenofibrate once daily for 3 month.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
n=25: will receive Placebo plus four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week.
Arm Title
fenofibrate group
Arm Type
Active Comparator
Arm Description
n=25: will receive fenofibrate 160mg once daily for 3 month plus four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week. .
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo tablet
Intervention Description
25 patients will receive four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week
Intervention Type
Drug
Intervention Name(s)
Fenofibrate 160mg
Other Intervention Name(s)
Lipanthyl 16omg
Intervention Description
25 patients will receive four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week in addition to 160mg fenofibrate once daily for 3 month.
Primary Outcome Measure Information:
Title
Nerve growth factor (NGF) Concentration
Description
Concentration of Nerve growth factor (NGF)
Time Frame
3 month
Title
Neurofilament light chain (NfL) protein Concentration
Description
Concentration of Neurofilament light chain (NfL) protein
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Incidence of neuropathic pain
Description
neuropathic pain using score from FACT/GOG NtX 12 questionnaire .
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: included a diagnosis breast cancer with age > 18 years. Naïve to chemotherapy Exclusion Criteria: Concurrent administration (statins , cyclosporine) . Advanced liver disease (defined as liver enzyme elevation >3-fold upper limit of normality, or cirrhosis); chronic kidney disease (CKD, defined as an eGFR <60 ml min-1 1.73 m-2); acute or chronic pancreatitis and diabetes. Patients with a history of allergy to fenofibrate. Concomitant use of opioids, anticonvulsants, tricyclic antidepressants, other neuropathic pain medication. Pregnancy or breast feeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rehab H Werida, Ass. Prof.
Phone
+201005359968
Email
rehabwrieda@pharm.dmu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Entesar Kamal Abdou Attia, Bachlor
Email
entesar.ka.95@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noha El bassiouny, Lecturer
Organizational Affiliation
Damanhour University
Official's Role
Study Director
Facility Information:
Facility Name
Damanhour Oncology Center
City
Damanhūr
State/Province
Elbehairah
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rehab H Werida, Ass. Prof.
Phone
01005359968
Email
rehabwrieda@pharm.dmu.edu.eg
First Name & Middle Initial & Last Name & Degree
Entesar Kamal Abdou Attia, Bachlor
Email
entesar.ka.95@gmail.com
First Name & Middle Initial & Last Name & Degree
Noha El Bassiouny, Lecturer

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26228675
Citation
Othman A, Benghozi R, Alecu I, Wei Y, Niesor E, von Eckardstein A, Hornemann T. Fenofibrate lowers atypical sphingolipids in plasma of dyslipidemic patients: A novel approach for treating diabetic neuropathy? J Clin Lipidol. 2015 Jul-Aug;9(4):568-75. doi: 10.1016/j.jacl.2015.03.011. Epub 2015 Apr 4.
Results Reference
background
PubMed Identifier
33434562
Citation
Caillaud M, Patel NH, White A, Wood M, Contreras KM, Toma W, Alkhlaif Y, Roberts JL, Tran TH, Jackson AB, Poklis J, Gewirtz DA, Damaj MI. Targeting Peroxisome Proliferator-Activated Receptor-alpha (PPAR- alpha) to reduce paclitaxel-induced peripheral neuropathy. Brain Behav Immun. 2021 Mar;93:172-185. doi: 10.1016/j.bbi.2021.01.004. Epub 2021 Jan 9.
Results Reference
background

Learn more about this trial

Fenofibrate Role in Breast Cancer Patients

We'll reach out to this number within 24 hrs