Clinical trial · Interventional
N-acetyl Cysteine Effect in Peripheral Neuropathy in Cancer Patients
Evaluation of The Effect of N-AcetylCysteine in The Prevention of Paclitaxel-Induced Peripheral Neuropathy in Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral Neuropathy Due to Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| high dose N-acetylcysteine | Dietary Supplement | — | UNRESOLVED |
| low dose N-acetylcysteine | Dietary Supplement | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- control
- description
- they will receive paclitaxel 80 mg/m2 once per week for 12 weeks only
- interventionNames
- Drug: Paclitaxel
- type
- EXPERIMENTAL
- label
- high dose N-acetyl cysteine
- description
- 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
- interventionNames
- Dietary Supplement: high dose N-acetylcysteine
- Drug: Paclitaxel
- type
- EXPERIMENTAL
- label
- low dose N-acetyl cysteine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDKhalefa 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. PMID 32601973