Trimetazidine Efficacy in Attenuating Paclitaxel-Induced Peripheral Neuropathy

Trial Title: Trimetazidine Efficacy in Attenuating Paclitaxel-Induced Peripheral Neuropathy

NCT ID: NCT06459193

Condition: Peripheral Neuropathy Due to Chemotherapy

Conditions: Official terms:
Peripheral Nervous System Diseases
Trimetazidine

Conditions: Keywords:
Paclitaxel
Trimetazidine
quality of life
nerve growth factor
peripheral neuropathy

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Drug
Intervention name: Trimetazidine
Description: Trimetazidine 35 mg tab once daily
Arm group label: Intervention

Intervention type: Drug
Intervention name: Placebo
Description: Placebo once daily
Arm group label: Control

Summary: 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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). Exclusion Criteria: - 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.

Gender: Female

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Minia Oncology Center

Address:
City: Minya
Zip: 61512
Country: Egypt

Status: Recruiting

Contact:
Last name: Asmaa Najm Iqbal Ahmed, Demonstrator

Phone: +201091965003
Email: asmaa.najm98@gmail.com

Contact backup:
Last name: Engy Ahmed Wahsh, Ass. Prof

Phone: +201003095692
Email: engywahsh@o6u.edu.eg

Start date: June 23, 2024

Completion date: November 30, 2024

Lead sponsor:
Agency: Minia University
Agency class: Other

Source: Minia University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06459193