Breast CancerNCT05813145
Fenofibrate Role in Breast Cancer Patients
A study testing Fenofibrate 160mg in people with Breast Cancer, run by Damanhour University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Fenofibrate 160mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 5 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- included a diagnosis breast cancer with age > 18 years.
- Naïve to chemotherapy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fenofibrate Role Against Chemotherapy Induced Peripheral Neurotoxicity in Breast Cancer Patients
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).
Read the detailed description
Ethical committee approval will be obtained from ethics committee of Faculty of Pharmacy, Damanhur University.
- All participants should agree to take part in this clinical study and will provide informed consent.
- fifty female patients with diagnosed breast cancer, who are candidates for will be recruited from Damanhur oncology center.
- 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.
- 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 .
- 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 .
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Results, conclusion, discussion, and recommendations will be given.
- Conditions
- Breast Cancer
- Being tested
- Placebo, Fenofibrate 160mg
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Placebo tablet
25 patients will receive four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week
Fenofibrate 160mgDrug
Also called Lipanthyl 16omg
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | n=25: will receive Placebo plus four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week. Receives: Drug: Placebo |
| fenofibrate group | Active comparator | 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.
. Receives: Drug: Fenofibrate 160mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve growth factor (NGF) Concentration
Concentration of Nerve growth factor (NGF)
Measured: 3 month
Neurofilament light chain (NfL) protein Concentration
Concentration of Neurofilament light chain (NfL) protein
Measured: 3 month
Secondary outcomes (1)
Incidence of neuropathic pain
neuropathic pain using score from FACT/GOG NtX 12 questionnaire .
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start1 Jan 2023
- Primary completion1 Aug 2024
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Werida, Damanhour University
- Investigators
- Noha El bassiouny, Lecturer, Study director, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813145
- Sponsor's protocol ID
- Fenofibrate in Breast Cancer
- Status last verified
- Jul 2025
- First submitted
- 16 Mar 2023
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26228675Caillaud 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.
PubMed 33434562
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fenofibrate Role Against Chemotherapy Induced Peripheral Neurotoxicity in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05813145
- Acronym / sponsor ID
- Fenofibrate in Breast Cancer
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- All participants should agree to take part in this clinical study and will provide informed consent.
- fifty female patients with diagnosed breast cancer, who are candidates for will be recruited from Damanhur oncology center.
- 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.
- 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 .
- 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 .
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Results, conclusion, discussion, and recommendations will be given.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Drug: Placebon=25: will receive Placebo plus four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week. |
| fenofibrate group | Active comparator | Drug: Fenofibrate 160mgn=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. . |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- included a diagnosis breast cancer with age > 18 years.
- Naïve to chemotherapy
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Placebo tablet25 patients will receive four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week | Drug | Placebo Group |
| Fenofibrate 160mgAlso: Lipanthyl 16omg25 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. | Drug | fenofibrate group |
Primary outcome
Nerve growth factor (NGF) Concentration
Time frame: 3 month
Concentration of Nerve growth factor (NGF)
Neurofilament light chain (NfL) protein Concentration
Time frame: 3 month
Concentration of Neurofilament light chain (NfL) protein
1 secondary outcome
Incidence of neuropathic pain
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Background: PubMed 26228675Othman 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.
- Background: PubMed 33434562Caillaud 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.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noha El bassiouny, Lecturer study director
Damanhour University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fenofibrate 160mg in people with Breast Cancer, run by Damanhour University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nerve growth factor (NGF) Concentration (time frame: 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05813145, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.