Status:
UNKNOWN
Role of Curcumin in Paclitaxel Induced PN
Lead Sponsor:
Ain Shams University
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
Brief Summary
Paclitaxel induced peripheral neuropathy is the most common and serious side effect associated with Paclitaxel treatment in breast cancer patients receiving Paclitaxel. The efficacy of antioxidant mo...
Detailed Description
The work is a prospective, randomized, open label controlled study. A total of 90 breast cancer female patients will be enrolled in the study. Eligible patients will simply be randomized using random ...
Eligibility Criteria
Inclusion
- Clinical diagnosis of early stage breast cancer with age \> 18 years.
- Performance status of the patients based on Eastern Cooperative Oncology Group (ECOG) from 0 to 2.
- Patients must receive paclitaxel 80 mg/m2 weekly or 175 mg/m2 every 3 weeks for 12 weeks.
- Patients clinical parameters should be (ANC ≥ 1500/mm3). Platelet count 100,000/mm3) (serum total bilirubin \< 1.5 mg/dl) and (creatinine \< 1.5 mg/dl).
Exclusion
- Patients they had any signs and symptoms of clinical neuropathy.
- Diabetes mellitus
- Patients receiving vitamin supplementation including vitamin B1, B6 and B12
- Patients receiving antidepressants, anticoagulants, opioids or anticonvulsants
- Patients had a hypersensitivity to curcumin.
Key Trial Info
Start Date :
August 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 10 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05966441
Start Date
August 30 2023
End Date
March 10 2024
Last Update
July 28 2023
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