A Phase 3 interventional study of Loratadine and Diosmin/ Hesperidin in Vinca Alkaloid Adverse Reaction, sponsored by Ain Shams University. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-02-17.
Sponsored by Ain Shams University · Phase 3, Interventional, and Prevention
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 ranged from 50% to 97%. In this study, the investigators will study the effect of using either loratadine or diosmin 450mg/ hesperidin 50 mg combination on neuropathy caused by Vinca alkaloids therapy. This study is a prospective, controlled, randomized, interventional and open-label clinical trial.
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 treatment protocol.
Group 2 (Loratadine group): 30 patients will receive One tablet 10 mg orally once daily starting with vincristine or vinblastine administration for three cycles.
Group 3 (hesperidin 50 mg/diosmin 450mg group): 30 patients will receive 50 mg Hesperidin and Micronized purified flavonoid fraction (MPFF) 450 diosmin combination one film coated tablet orally twice daily starting with vincristine or vinblastine administration for three cycles .
Vincristine or Vinblastine dose will be adjusted as follows: Serum bilirubin 1.5 to 3 mg/dL or transaminases 2 to 3 times ULN or alkaline phosphatase increased: Administer 50% of dose.
Treatment allocation will follow a predefined randomization list and it will be computer generated.
Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
30 patients will receive Vincristine 1.5 mg/m2 (maximum: 2 mg) or Vinblastine 6 mg/m2 according to treatment protocol.
30 patients will receive One tablet 10 mg orally once daily starting with vincristine or vinblastine administration for three cycles
Drug: Loratadine
30 patients will receive 50 mg Hesperidin and Micronized purified flavonoid fraction (MPFF) 450 diosmin combination one film coated tablet orally twice daily starting with vincristine or vinblastine administration for three cycles
Drug: Diosmin/ Hesperidin
Intervention is given to study its' effect on vinca alkaloids induced neuropathy
Intervention is given to study its effect on vinca alkaloids induced neuropathy
Assessing the efficacy of loratadine or diosmin 450mg/ hesperidin 50 mg on neuropathy pain intensity of Vinca alkaloids neuropathy compared to routine practice.
Measure of average pain intensity assessed by Numeric Pain Rating Scale (NS) change from baseline to after three cycles of vinca alkaloids therapy
Time frame: At baseline and after three cycles of vinca alkaloids (each cycle is 28 days)
Assessing the efficacy of loratadine or diosmin 450mg/ hesperidin 50 mg on pain quality (i.e. sensory and pain) of Vinca alkaloids neuropathy compared to routine practice.
Neuropathic Pain in 4 questions (DN4) change from baseline to after three cycles of vinca alkaloids therapy
Time frame: At baseline and after three cycles of vinca alkaloids (each cycle is 28 days)
Assessing the efficacy of loratadine or diosmin 450mg/ hesperidin 50 mg on symptoms of peripheral neuropathy of Vinca alkaloids compared to routine practice.
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) change from baseline to after three cycles of vinca alkaloids therapy
Time frame: At baseline and after three cycles of vinca alkaloids (each cycle is 28 days)
Assessing the efficacy of loratadine or diosmin 450mg/ hesperidin 50 mg on development of Vinca alkaloids neuropathy compared to routine practice.
Measuring Peripheral blood Neurofilament Proteins and IL-1 beta change from baseline to after three cycles of vinca alkaloids therapy
Time frame: At baseline and after three cycles of vinca alkaloids (each cycle is 28 days)
Evaluating the effect of loratadine versus diosmin 450mg/hesperidin 50 mg on the time to onset of neuropathy caused by Vinca alkaloids compared to control group.
Measure the time of neuropathy onset in patients
Time frame: from baseline to after Three cycles of vinca alkaloids (each cycle is 28 days)
Evaluating the Number of participants with Adverse Events of loratadine versus hesperidin 50 mg/diosmin 450mg by monitoring patients for undesirable effects
The number of patients developing neuropathy as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: from baseline to after Three cycles of vinca alkaloids (each cycle is 28 days)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Ain Shams University