Peripheral Neuropathy Due to ChemotherapyPhase 1/2NCT06459193
Trimetazidine Efficacy in Attenuating Paclitaxel-Induced Peripheral Neuropathy
A Phase 1/2 study testing Trimetazidine in people with Peripheral Neuropathy Due to Chemotherapy, run by Minia University at 1 site in Egypt.
Trial summary
This proof-of-concept study evaluated the effect of Trimetazidine on the incidence of paclitaxel-induced peripheral neuropathy in patients with breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Peripheral Neuropathy Due to Chemotherapy
- What is being tested?
- Trimetazidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Jun 2024to 27 Mar 2025
- Phase
- Phase 1/2
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer patients who will receive paclitaxel.
- Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
- Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count≥100,000/mm3), liver function (serum total bilirubin <1.5 mg/dl), renal function (creatinine < 1.5 mg/dl).
Who cannot join
- Patients with signs and symptoms of clinical neuropathy at baseline.
- Patients with diabetes mellitus, alcoholic disease, heart failure, pregnant or lactating women.
- Patients receiving vitamin/ supplementation drugs that interfere with the study intervention.
- Patients with contraindications to trimetazidine including Parkinson's disease, Parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Trimetazidine in Alleviating Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients
This proof-of-concept study evaluated the effect of Trimetazidine on the incidence of paclitaxel-induced peripheral neuropathy in patients with breast cancer.
Read the detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) is a major adverse effect of many commonly used chemotherapeutic agents that greatly affect patient quality of life. Paclitaxel (PTX), one of the main neurotoxic classes of anticancer drugs, is used to treat several types of solid tumors, including breast cancer. Development of PTX-induced peripheral neuropathy (PIPN) during cancer treatment requires dose reduction limiting its clinical benefits.
The only currently recognized prophylactic measure for chemotherapy-induced peripheral neuropathy (CIPN) is monitoring for pre-existing neuropathies and then the early detection of clinical symptoms of neuropathy in subjects undergoing neurotoxic chemotherapy treatment.
Preclinical data has shown that the neuroprotective effect of trimetazidine (TMZ) can attenuate PIPN.
TMZ has preclinical evidence about its preventive capacity against peripheral neuropathy. Which represents a possible prophylactic strategy for attenuating PIPN. TMZ is commercially available in various preparations that are relatively affordable and well-tolerated, making it a valid candidate for clinical evaluation.
- Being tested
- Trimetazidine, Placebo
- Keywords
- Paclitaxel, Trimetazidine, quality of life, nerve growth factor, peripheral neuropathy
- Medical subject headings
- Hereditary Sensory and Autonomic Neuropathies, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrimetazidineDrug
Trimetazidine 35 mg tab once daily
PlaceboDrug
Placebo once daily
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Trimetazidine Tablet 35 mg once daily for the treatment period Receives: Drug: Trimetazidine |
| Control | Placebo comparator | Placebo once daily for the treatment period Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria
Number of patients reported neuropathy from paclitaxel. a 1 to 5 graded scale; where grade (1) is the minimum value and grade (5) is the maximum value, a greater grades mean greater symptomatic burden.
Measured: weekly for up to 8 weeks
Patient's Quality of Life
measures the quality of life using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity FACT/GOG-NTX (Version 4) questionnaire.
A total score ranging from 0 (minimum value) to 44 (maximum value), where lower scores mean greater symptomatic burden.
Measured: at baseline, at the end of 4 weeks and at the end of 8 weeks
Secondary outcomes (3)
Changes in serum levels of biomarker namely nerve growth factor (NGF).
measuring serum level of nerve growth factor using enzyme-linked immunoassay (ELISA) Kit.
Measured: at baseline and at end of 8 weeks
Adverse effects of using trimetazidine in preventing Paclitaxel Induced Peripheral Neuropathy.
any adverse/ side effect will be evaluated.
Measured: at baseline and weekly up to 8 week
Severity of chemotherapy induced-peripheral neuropathy.
The severity of paclitaxel-induced peripheral neuropathy using VAS visual analogue scale.
a 10-cm line that represents a continuum between "no pain" and "worst pain."
Measured: at baseline, at the end of 4 weeks and at the end of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start23 Jun 2024
- Primary completion28 Jan 2025
- Study completion27 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peripheral Neuropathy Due to ChemotherapyStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Najm Iqbal Ahmed, Minia University
- Investigators
- Asmaa N. Iqbal Ahmed, Demonstrator, Principal investigator, Clinical Pharmacy Department, Faculty of Pharmacy, Minia University, Minia, Egypt.Engy A. Wahsh, Asst. Prof., Study director, Clinical Pharmacy Department, Faculty of Pharmacy, October 6 University, Giza, EgyptFatma M. Mady, Professor, Study chair, Pharmaceutics department, Faculty of Pharmacy, Minia University, Minia, Egypt.Eman M. Sadek, Lecturer, Study director, Clinical pharmacy Department, Faculty of Pharmacy, Minia University, Minia, Egypt.Ahmed Mostafa Abd-Elaziz, Lecturer, Study director, Department of Clinical Oncology, Faculty of Medicine, Minia University, Minia, Egypt.Noha Mahmood Abd-Allah, Lecturer, Study director, Department of Clinical Pathology, Faculty of Medicine, Minia University, Minia, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459193
- Sponsor's protocol ID
- 2301006
- Status last verified
- Mar 2025
- First submitted
- 10 Jun 2024
- Last updated
- 30 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khalefa HG, Shawki MA, Aboelhassan R, El Wakeel LM. Evaluation of the effect of N-acetylcysteine on the prevention and amelioration of paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled study. Breast Cancer Res Treat. 2020 Aug;183(1):117-125. doi: 10.1007/s10549-020-05762-8. Epub 2020 Jun 29.
PubMed 32601973Haroun EA, Mansour NO, Eltantawy A, Shams MEE. Effect of cilostazol on preventing paclitaxel-induced neuropathy in patients with breast cancer: A randomized controlled trial. Pharmacotherapy. 2023 Sep;43(9):872-882. doi: 10.1002/phar.2830. Epub 2023 Jun 12.
PubMed 37199288Hammad ASA, Sayed-Ahmed MM, Abdel Hafez SMN, Ibrahim ARN, Khalifa MMA, El-Daly M. Trimetazidine alleviates paclitaxel-induced peripheral neuropathy through modulation of TLR4/p38/NF-kappaB and klotho protein expression. Chem Biol Interact. 2023 May 1;376:110446. doi: 10.1016/j.cbi.2023.110446. Epub 2023 Mar 9.
PubMed 36898573Iqbal AN, Mady FM, Sadek EM, Abdullah NM, Abdel-Azeez AM, Shorog E, Wahsh EA. Evaluation of trimetazidine in alleviating paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled trial. Front Pharmacol. 2026 Feb 2;17:1748399. doi: 10.3389/fphar.2026.1748399. eCollection 2026.
PubMed 41704280
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Trimetazidine in Alleviating Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06459193
- Acronym / sponsor ID
- 2301006
- Keywords
- Paclitaxel, Trimetazidine, quality of life, nerve growth factor, peripheral neuropathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 23 Jun 2024 (actual)
- Primary completion
- 28 Jan 2025 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 14 Jun 2024 (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.
This proof-of-concept study evaluated the effect of Trimetazidine on the incidence of paclitaxel-induced peripheral neuropathy in patients with breast cancer.
Detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) is a major adverse effect of many commonly used chemotherapeutic agents that greatly affect patient quality of life. Paclitaxel (PTX), one of the main neurotoxic classes of anticancer drugs, is used to treat several types of solid tumors, including breast cancer. Development of PTX-induced peripheral neuropathy (PIPN) during cancer treatment requires dose reduction limiting its clinical benefits.
The only currently recognized prophylactic measure for chemotherapy-induced peripheral neuropathy (CIPN) is monitoring for pre-existing neuropathies and then the early detection of clinical symptoms of neuropathy in subjects undergoing neurotoxic chemotherapy treatment.
Preclinical data has shown that the neuroprotective effect of trimetazidine (TMZ) can attenuate PIPN.
TMZ has preclinical evidence about its preventive capacity against peripheral neuropathy. Which represents a possible prophylactic strategy for attenuating PIPN. TMZ is commercially available in various preparations that are relatively affordable and well-tolerated, making it a valid candidate for clinical evaluation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: TrimetazidineTrimetazidine Tablet 35 mg once daily for the treatment period |
| Control | Placebo comparator | Drug: PlaceboPlacebo once daily for the treatment period |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Breast cancer patients who will receive paclitaxel.
- Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
- Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count≥100,000/mm3), liver function (serum total bilirubin <1.5 mg/dl), renal function (creatinine < 1.5 mg/dl).
Key exclusion criteria (4 listed)
- Patients with signs and symptoms of clinical neuropathy at baseline.
- Patients with diabetes mellitus, alcoholic disease, heart failure, pregnant or lactating women.
- Patients receiving vitamin/ supplementation drugs that interfere with the study intervention.
- Patients with contraindications to trimetazidine including Parkinson's disease, Parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders.
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 |
|---|---|---|
| TrimetazidineTrimetazidine 35 mg tab once daily | Drug | Intervention |
| PlaceboPlacebo once daily | Drug | Control |
Primary outcome
Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria
Time frame: weekly for up to 8 weeks
Number of patients reported neuropathy from paclitaxel. a 1 to 5 graded scale; where grade (1) is the minimum value and grade (5) is the maximum value, a greater grades mean greater symptomatic burden.
Patient's Quality of Life
Time frame: at baseline, at the end of 4 weeks and at the end of 8 weeks
measures the quality of life using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity FACT/GOG-NTX (Version 4) questionnaire. A total score ranging from 0 (minimum value) to 44 (maximum value), where lower scores mean greater symptomatic burden.
3 secondary outcomes
Changes in serum levels of biomarker namely nerve growth factor (NGF).
Time frame: at baseline and at end of 8 weeks
Adverse effects of using trimetazidine in preventing Paclitaxel Induced Peripheral Neuropathy.
Time frame: at baseline and weekly up to 8 week
Severity of chemotherapy induced-peripheral neuropathy.
Time frame: at baseline, at the end of 4 weeks and at the end of 8 weeks
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 30 Mar 2025.
- Background: PubMed 32601973Khalefa HG, Shawki MA, Aboelhassan R, El Wakeel LM. Evaluation of the effect of N-acetylcysteine on the prevention and amelioration of paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled study. Breast Cancer Res Treat. 2020 Aug;183(1):117-125. doi: 10.1007/s10549-020-05762-8. Epub 2020 Jun 29.
- Background: PubMed 37199288Haroun EA, Mansour NO, Eltantawy A, Shams MEE. Effect of cilostazol on preventing paclitaxel-induced neuropathy in patients with breast cancer: A randomized controlled trial. Pharmacotherapy. 2023 Sep;43(9):872-882. doi: 10.1002/phar.2830. Epub 2023 Jun 12.
- Background: PubMed 36898573Hammad ASA, Sayed-Ahmed MM, Abdel Hafez SMN, Ibrahim ARN, Khalifa MMA, El-Daly M. Trimetazidine alleviates paclitaxel-induced peripheral neuropathy through modulation of TLR4/p38/NF-kappaB and klotho protein expression. Chem Biol Interact. 2023 May 1;376:110446. doi: 10.1016/j.cbi.2023.110446. Epub 2023 Mar 9.
- Derived from this study: PubMed 41704280Iqbal AN, Mady FM, Sadek EM, Abdullah NM, Abdel-Azeez AM, Shorog E, Wahsh EA. Evaluation of trimetazidine in alleviating paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled trial. Front Pharmacol. 2026 Feb 2;17:1748399. doi: 10.3389/fphar.2026.1748399. eCollection 2026.
- Individual participant dataSharing planned: No
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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.
Asmaa N. Iqbal Ahmed, Demonstrator principal investigator
Clinical Pharmacy Department, Faculty of Pharmacy, Minia University, Minia, Egypt.
Engy A. Wahsh, Asst. Prof. study director
Clinical Pharmacy Department, Faculty of Pharmacy, October 6 University, Giza, Egypt
Fatma M. Mady, Professor study chair
Pharmaceutics department, Faculty of Pharmacy, Minia University, Minia, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Trimetazidine in people with Peripheral Neuropathy Due to Chemotherapy, run by Minia 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 3 inclusion and 4 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 30 Mar 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria (time frame: weekly for up to 8 weeks). 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 NCT06459193, which also lists 4 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 30 Mar 2025.