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Completed

NCT Number: NCT03492047

N-acetyl Cysteine Effect in Peripheral Neuropathy in Cancer Patients

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

AinShams University Hospitals

Cairo, 11566, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (>18 years old).
  • Breast cancer patients who will receive adjuvant weekly paclitaxel for 12 cycles.
  • ECOG performance status 0-2
  • 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 who have any of the following:
  • Clinical neuropathy.
  • Diabetes mellitus.
  • Patients receiving vitamin B1, B6, B12,or other vitamin supplemental therapy.
  • Patients receiving antidepressants, opioids, adjuvant analgesic agents (eg, anticonvulsants, clonazepam, or mexiletine), topical analgesics, and amifostine.
  • Hypersensitivity to NAC.

Treatment and study plan

low dose N-acetylcysteine

Dietary Supplement

N-acetylcysteine 600mg twice daily

high dose N-acetylcysteine

Dietary Supplement

N-acetylcysteine 1200mg twice daily

paclitaxel

Drug

Paclitaxel 80mg /m2 IV

Primary outcomes

  1. Incidence of chemotherapy induced-peripheral neuropathy

    Time frame: up to 12 week

    Number of patients reported neuropathy from paclitaxel

Secondary outcomes

  1. 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

  2. Adverse effects

    Time frame: at baseline and each cycle up to 12 week

    any adverse/ side effect will be evaluated

  3. 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.

Other outcomes

  1. the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT-GOG-NTX) subscale

    Time frame: weekly up to 12 week

    measures quality of life related to signs and symptoms of paclitaxel induced peripheral neuropathy

  2. serum nerve growth factor

    Time frame: at baseline and after 12 week

    measuring serum level of nerve growth factor using ELISA KIT

  3. serum malionaldehyde

    Time frame: at baseline and after 12 week

    measuring serum level of maliomaldehyde using spectrophometric kit

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Collaborators

  • Nasser Institute For Research and Treatment

Registry information

Official study title

Evaluation of The Effect of N-AcetylCysteine in The Prevention of Paclitaxel-Induced Peripheral Neuropathy in Cancer Patients

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 10, 2018
Registry last updated
Feb 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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