Status:
UNKNOWN
Evaluation of The Effect of Loratadine Versus Diosmin/Hesperidin Combination on Vinca Alkaloids Induced Neuropathy
Lead Sponsor:
Ain Shams University
Conditions:
Vinca Alkaloid Adverse Reaction
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
All vinca alkaloids causes neuropathy. The incidence of peripheral neuropathy is 30 %-40 % in patients treated with vincristine. The incidence of long term neurological adverse events from vinblastine...
Detailed Description
Ninety patients will be randomly assigned to three groups as follows: Group 1 (Control group): 30 patients will receive Vincristine 1.5 mg/m2 (maximum: 2 mg) or Vinblastine 6 mg/m2 according to treat...
Eligibility Criteria
Inclusion
- Patients prescribed vincristine or vinblastine according to standard protocols.
- Adult patients older than18 years.
- Patients willing to participate in the study and sign the informed consent.
- Adequate bone barrow function (platelet count\> 150 \*103per microliter, absolute neutrophil count\> 500 per microliter)
- Eastern cooperative oncology group (ECOG) performance status Grade 0-2
Exclusion
- Hypersensitivity or contraindication to loratadine, hesperidin or diosmin combination or any component of the formulation.
- Pre-existence or history of peripheral neuropathy due to a cause different from Vinca alkaloids induced neuropathy.
- Receiving any other medication known to cause neuropathy.
- Receiving medications with drug interaction grade X with Loratadine as Thalidomide, Tiotropium or Orphenadrine.
- Women of childbearing potential not using an effective contraceptive method.
- Pregnancy or breastfeeding.
- Inability to understand patients' information and informed consent form.
- Severe hepatic impairment.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05243706
Start Date
March 1 2022
End Date
December 30 2023
Last Update
February 17 2022
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