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Fenofibrate Role in Breast Cancer Patients

Sponsor
Damanhour University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05813145
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
13
Anticipated Duration (Months)
3.8
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Placebo
  • Drug: Fenofibrate 160mg
 N/A

Detailed Description

Ethical committee approval will be obtained from ethics committee of Faculty of Pharmacy, Damanhur University.

  1. All participants should agree to take part in this clinical study and will provide informed consent.

  2. fifty female patients with diagnosed breast cancer, who are candidates for will be recruited from Damanhur oncology center.

  3. 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.

  1. 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 .

  1. 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 .

  2. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.

  3. Results, conclusion, discussion, and recommendations will be given.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Fenofibrate Role Against Chemotherapy Induced Peripheral Neurotoxicity in Breast Cancer Patients
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo Group

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

Drug: Placebo
25 patients will receive four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week
Other Names:
  • Placebo tablet

    		•
    Active Comparator: fenofibrate group

    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. .

    Drug: Fenofibrate 160mg
    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.
    Other Names:
  • Lipanthyl 16omg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Nerve growth factor (NGF) Concentration [3 month]

      Concentration of Nerve growth factor (NGF)

    2. Neurofilament light chain (NfL) protein Concentration [3 month]

      Concentration of Neurofilament light chain (NfL) protein

    Secondary Outcome Measures

    1. Incidence of neuropathic pain [6 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    1. included a diagnosis breast cancer with age > 18 years.

    2. Naïve to chemotherapy

    Exclusion Criteria:

    1. Concurrent administration (statins , cyclosporine) .

    2. 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.

    3. Patients with a history of allergy to fenofibrate.

    4. Concomitant use of opioids, anticonvulsants, tricyclic antidepressants, other neuropathic pain medication.

    5. Pregnancy or breast feeding.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Damanhour Oncology Center Damanhūr Elbehairah Egypt 31527

    Sponsors and Collaborators

    • Damanhour University

    Investigators

    • Study Director: Noha El bassiouny, Lecturer, Damanhour University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Rehab Werida, Principal Investigator, Damanhour University
    ClinicalTrials.gov Identifier:
    NCT05813145
    Other Study ID Numbers:
    • Fenofibrate in Breast Cancer
    First Posted:
    Apr 14, 2023
    Last Update Posted:
    Apr 14, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Fenofibrate

    Study Results

    No Results Posted as of Apr 14, 2023