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| Name | Class |
|---|---|
| Nasser Institute For Research and Treatment | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Active Comparator | they will receive paclitaxel 80 mg/m2 once per week for 12 weeks only |
|
| high dose N-acetyl cysteine | Experimental | 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 |
|
| low dose N-acetyl cysteine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low dose N-acetylcysteine | Dietary Supplement | N-acetylcysteine 600mg twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of chemotherapy induced-peripheral neuropathy | Number of patients reported neuropathy from paclitaxel | up to 12 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Adverse effects |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| serum nerve growth factor |
Inclusion Criteria:
Exclusion Criteria:
Patients who have any of the following:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Hadeer G Khalefa, master | Nassar institute for research and treatment hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AinShams University Hospitals | Cairo | 11566 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32601973 | Derived | Khalefa HG, Shawki MA, Aboelhassan R, El Wakeel LM. Evaluation of the effect of N-acetylcysteine on the prevention and amelioration of paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled study. Breast Cancer Res Treat. 2020 Aug;183(1):117-125. doi: 10.1007/s10549-020-05762-8. Epub 2020 Jun 29. |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| high dose N-acetylcysteine | Dietary Supplement | N-acetylcysteine 1200mg twice daily |
|
| Paclitaxel | Drug | Paclitaxel 80mg /m2 IV |
|
any adverse/ side effect will be evaluated
| at baseline and each cycle up to 12 week |
| 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 |
measuring serum level of nerve growth factor using ELISA KIT
| at baseline and after 12 week |
| serum malionaldehyde | measuring serum level of maliomaldehyde using spectrophometric kit | at baseline and after 12 week |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |