Peripheral Neuropathy Due to Chemotherapy
Conditions
Keywords
paclitaxel, peripheral neuropathy, N-acetyl cysteine
Brief 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.
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_SUPPLEMENTlow dose N-acetylcysteine
N-acetylcysteine 600mg twice daily
DIETARY_SUPPLEMENThigh dose N-acetylcysteine
N-acetylcysteine 1200mg twice daily
DRUGPaclitaxel
Paclitaxel 80mg /m2 IV
Sponsors
Nasser Institute For Research and Treatment
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of chemotherapy induced-peripheral neuropathy | up to 12 week | Number of patients reported neuropathy from paclitaxel |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| severity of chemotherapy induced-peripheral neuropathy | at baseline and before each cycle up to 12 week | severity of paclitaxel induced peripheral neuropathy using NCI-CTCAE criteria |
| Adverse effects | at baseline and each cycle up to 12 week | any adverse/ side effect will be evaluated |
Other
| Measure | Time frame | Description |
|---|---|---|
| the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT-GOG-NTX) subscale | weekly up to 12 week | measures quality of life related to signs and symptoms of paclitaxel induced peripheral neuropathy |
| serum nerve growth factor | at baseline and after 12 week | measuring serum level of nerve growth factor using ELISA KIT |
| serum malionaldehyde | at baseline and after 12 week | measuring serum level of maliomaldehyde using spectrophometric kit |
Countries
Egypt
Outcome results
None listed