N-acetyl Cysteine Effect in Peripheral Neuropathy in Cancer Patients

Overview

The purpose of the study is to evaluate the effect of N-acetyl cysteine in combination with paclitaxel on the clinical outcomes of patients with peripheral neuropathy, paclitaxel-induced peripheral neuropathy affect quality of life in cancer patients.

new therapeutic approches such as the antioxidant N-acetyl cysteine, showed to has neuroprotective effect, the aim of the study is to evaluate the effect of N- acetylcysteine(NAC) administration in the prevention of paclitaxel-Induced peripheral neuropathy.

Full Title of Study: “Evaluation of The Effect of N-AcetylCysteine in The Prevention of Paclitaxel-Induced Peripheral Neuropathy in Cancer Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 1, 2019

Detailed Description

Paclitaxel is a first-line chemotherapeutic treatment of solid tumors. Neuronal damage also seems to have a major role in paclitaxel-induced neuropathic pain, paclitaxel contributes to ROS formation (superoxide, hydroxyl radical, nitric oxide and hydrogen peroxide) in neuronal mitochondria that are involved in nerve injury-induced.

N-acetylcysteine (NAC) is a cysteine pro-drug and glutathione (GSH) precursor which is a protective agent and detoxifies and scavenges reactive oxygen species (ROS), which seems to help normalize the oxidative status.

It has been reported that high dose of N-acetylcysteine shown to Prevent retrograde motor neuron death after neonatal peripheral nerve injury and significantly increases motor neuron survival, which may improve functional outcomes after obstetrical brachial plexus injury in rats.

Also, it has been reported that NAC significantly inhibited CCI-induced microglia activation but elicited no notable effects on astrocytes. These results demonstrate an effective and safe approach that has been used clinically to alleviate neuropathic pain via the powerful inhibition of the activation of MMPs in rats.

N-acetylcysteine has been shown to have neuroprotective effects against oxaliplatin-based adjuvant chemotherapy in colon cancer patients with Oral administration of N-acetylcysteine1,200 mg) was given one and a half hours before each oxaliplatin administration.

Interventions

  • Dietary Supplement: low dose N-acetylcysteine
    • N-acetylcysteine 600mg twice daily
  • Dietary Supplement: high dose N-acetylcysteine
    • N-acetylcysteine 1200mg twice daily
  • Drug: Paclitaxel
    • Paclitaxel 80mg /m2 IV

Arms, Groups and Cohorts

  • Active Comparator: control
    • they will receive paclitaxel 80 mg/m2 once per week for 12 weeks only
  • Experimental: high dose N-acetyl cysteine
    • they will receive paclitaxel 80 mg/m2 once per week for 12 weeks and high dose N-acetylcysteine (1200 mg twice daily) for the paclitaxel treatment period
  • Experimental: low dose N-acetyl cysteine
    • they will receive paclitaxel 80 mg/m2 once per week for 12 weeks and low dose N-acetylcysteine (600mg twice daily) for the paclitaxel treatment period.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of chemotherapy induced-peripheral neuropathy
    • Time Frame: up to 12 week
    • Number of patients reported neuropathy from paclitaxel

Secondary Measures

  • severity of chemotherapy induced-peripheral neuropathy
    • Time Frame: at baseline and before each cycle up to 12 week
    • severity of paclitaxel induced peripheral neuropathy using NCI-CTCAE criteria
  • Adverse effects
    • Time Frame: at baseline and each cycle up to 12 week
    • any adverse/ side effect will be evaluated
  • severity of chemotherapy induced-peripheral neuropathy
    • Time Frame: at baseline, at the end of 6 cycle and at the end of 12 cycles
    • severity of chemotherapy induced-peripheral neuropathy using modified total neuropathy score ,Each neuropathy item is scored by a physician on a 0-4 scale the scores are summed to obtain a total score, modified total neuropathy score score ranges from 0-24 with higher total scores indicate more severe neuropathy.

Participating in This Clinical Trial

Inclusion Criteria

1. Adult patients (>18 years old).

2. Breast cancer patients who will receive adjuvant weekly paclitaxel for 12 cycles.

3. ECOG performance status 0-2

4. 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

1. Patients who have any of the following:

  • Clinical neuropathy.
  • Diabetes mellitus.

2. Patients receiving vitamin B1, B6, B12,or other vitamin supplemental therapy.

3. Patients receiving antidepressants, opioids, adjuvant analgesic agents (eg, anticonvulsants, clonazepam, or mexiletine), topical analgesics, and amifostine.

4. Hypersensitivity to NAC.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ain Shams University
  • Collaborator
    • Nasser Institute For Research and Treatment
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hadeer Gamal Khalefa, pharmacist – Nasser Institute For Research and Treatment
  • Overall Official(s)
    • Hadeer G Khalefa, master, Principal Investigator, Nassar institute for research and treatment hospital

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