N-acetyl Cysteine Effect in Peripheral Neuropathy in Cancer Patients

Peripheral Neuropathy Due to Chemotherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03492047
• Other study ID #: PHCL93
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: February 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 30, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peripheral Neuropathy Due to Chemotherapy

Intervention

Dietary Supplement:
• low dose N-acetylcysteine
N-acetylcysteine 600mg twice daily
• high dose N-acetylcysteine
N-acetylcysteine 1200mg twice daily

Drug:
• Paclitaxel
Paclitaxel 80mg /m2 IV

Locations

Country	Name	City	State
Egypt	AinShams University Hospitals	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams University	Nasser Institute For Research and Treatment

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT-GOG-NTX) subscale	measures quality of life related to signs and symptoms of paclitaxel induced peripheral neuropathy	weekly up to 12 week
Other	serum nerve growth factor	measuring serum level of nerve growth factor using ELISA KIT	at baseline and after 12 week
Other	serum malionaldehyde	measuring serum level of maliomaldehyde using spectrophometric kit	at baseline and after 12 week
Primary	Incidence of chemotherapy induced-peripheral neuropathy	Number of patients reported neuropathy from paclitaxel	up to 12 week
Secondary	severity of chemotherapy induced-peripheral neuropathy	severity of paclitaxel induced peripheral neuropathy using NCI-CTCAE criteria	at baseline and before each cycle up to 12 week
Secondary	Adverse effects	any adverse/ side effect will be evaluated	at baseline and each cycle up to 12 week
Secondary	severity of chemotherapy induced-peripheral neuropathy	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.	at baseline, at the end of 6 cycle and at the end of 12 cycles