N-acetyl Cysteine Effect in Peripheral Neuropathy in Cancer Patients
Keywords
Coimriú
Cur síos
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.
Dátaí
| Fíoraithe Deireanach: | 01/31/2020 |
| Cuireadh isteach den chéad uair: | 03/01/2018 |
| Clárú Measta Curtha isteach: | 04/01/2018 |
| Arna chur suas ar dtús: | 04/09/2018 |
| Nuashonrú Deireanach Curtha isteach: | 02/24/2020 |
| Nuashonrú Deireanach Postáilte: | 02/26/2020 |
| Dáta Tosaigh an Staidéir Iarbhír: | 03/31/2018 |
| Dáta Críochnaithe Bunscoile Measta: | 03/31/2019 |
| Dáta Críochnaithe an Staid Mheasta: | 06/29/2019 |
Coinníoll nó galar
Idirghabháil / cóireáil
Dietary Supplement: low dose N-acetyl cysteine
Dietary Supplement: high dose N-acetyl cysteine
Drug: Paclitaxel
Céim
Grúpaí Láimhe
| Lámh | Idirghabháil / cóireáil |
|---|---|
| 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 | Dietary Supplement: high dose N-acetyl cysteine N-acetylcysteine 1200mg twice daily |
| 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. | Dietary Supplement: low dose N-acetyl cysteine N-acetylcysteine 600mg twice daily |
Critéir Incháilitheachta
| Aois Incháilithe le haghaidh Staidéir | 18 Years Chun 18 Years |
| Gnéas Incháilithe le haghaidh Staidéir | All |
| Glacann Oibrithe Deonacha Sláintiúla | Sea |
| Critéir | 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. |
Toradh
Bearta Toraidh Príomhúla
1. Incidence of chemotherapy induced-peripheral neuropathy [up to 12 week]
Bearta Torthaí Tánaisteacha
1. severity of chemotherapy induced-peripheral neuropathy [at baseline and before each cycle up to 12 week]
2. Adverse effects [at baseline and each cycle up to 12 week]
3. severity of chemotherapy induced-peripheral neuropathy [at baseline, at the end of 6 cycle and at the end of 12 cycles]
Bearta Toraidh Eile
1. the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT-GOG-NTX) subscale [weekly up to 12 week]
2. serum nerve growth factor [at baseline and after 12 week]
3. serum malionaldehyde [at baseline and after 12 week]
