NCT05966441

Role of Curcumin in Paclitaxel Induced PN

Name: Clinical Trial NCT05966441
Creator: Ain Shams University
Keywords: Chemotherapy-induced Peripheral Neuropathy, Curcumin, Phase 2, dietary supplement, clinical trial

Evaluating the Effect of Curcumin in Preventing Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients

Ain Shams University·Phase 2·ClinicalTrials.gov·dietary supplementNot yet recruiting

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Study focus

Disease/Condition: Chemotherapy-induced Peripheral Neuropathy
Drug/Device/Intervention: Curcumin
Study type: Interventional
Intervention type: dietary supplement

Sponsor & location

Primary sponsor: Ain Shams University

Timeline & enrollment

Phase: Phase 2
Start date: Aug 30, 2023
End date: Mar 10, 2024
Enrollment: 80 participants

Primary outcome

Evaluate the effect of Curcumin on the incidence and severity of paclitaxel-induced peripheral neuropathy (PIPN) in breast cancer patients.,Evaluate the effect of Curcumin on the damage of nerve fibers induced by paclitaxel.

Summary

Paclitaxel induced peripheral neuropathy is the most common and serious side effect associated with Paclitaxel treatment in breast cancer patients receiving Paclitaxel.  The efficacy of antioxidant molecules as neuroprotective strategies to preventing the development of peripheral neuropathy has been investigated in preclinical and clinical studies. Vitamin E and Glutathione have been explored as adjuvant therapies to preventing taxane-induced peripheral neuropathy. Other tested neuroprotective treatments with limited success include amifostine, glutamine and acetyl l-carnitine. Curcumin's antioxidant capacity is similar to other potent antioxidants, such as trolox (a vitamin E analog). Curcumin inhibits lipid peroxidation in different tissues, regulates intracellular levels of antioxidant enzymes (e.g., catalase, glutathione peroxidase and superoxide dismutase) and is an effective intracellular reactive oxygen species (ROS) scavenger.  The investigators are going to investigate the neuroprotective effect of Curcumin against Paclitaxel induced peripheral neuropathy.

ICD-10 classifications

Drug-induced polyneuropathyParaneoplastic neuromyopathy and neuropathyPolyneuropathy due to other toxic agentsIdiopathic peripheral autonomic neuropathyIdiopathic progressive neuropathy

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05966441
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT05966441 through Pure Global AI's free database. This Phase 2 trial is sponsored by Ain Shams University and is currently Not yet recruiting. The study focuses on Chemotherapy-induced Peripheral Neuropathy. Target enrollment is 80 participants.

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