Evaluation of The Effect of Loratadine Versus Diosmin/Hesperidin Combination on Vinca Alkaloids Induced Neuropathy

Ain Shams University

Status and phase: Unknown; Phase 3

Conditions: Vinca Alkaloid Adverse Reaction

Treatments: Drug: Diosmin/ Hesperidin; Drug: Loratadine

Study type: Interventional

Funder types: Other

Identifiers

NCT05243706

AinShamsU2

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients prescribed vincristine or vinblastine according to standard protocols.
2. Adult patients older than18 years.
3. Patients willing to participate in the study and sign the informed consent.
4. Adequate bone barrow function (platelet count> 150 *103per microliter, absolute neutrophil count> 500 per microliter)
5. Eastern cooperative oncology group (ECOG) performance status Grade 0-2

Exclusion criteria

1. Hypersensitivity or contraindication to loratadine, hesperidin or diosmin combination or any component of the formulation.
2. Pre-existence or history of peripheral neuropathy due to a cause different from Vinca alkaloids induced neuropathy.
3. Receiving any other medication known to cause neuropathy.
4. Receiving medications with drug interaction grade X with Loratadine as Thalidomide, Tiotropium or Orphenadrine.
5. Women of childbearing potential not using an effective contraceptive method.
6. Pregnancy or breastfeeding.
7. Inability to understand patients' information and informed consent form.
8. Severe hepatic impairment.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 3 patient groups

Control group

No Intervention group

Description:

30 patients will receive Vincristine 1.5 mg/m2 (maximum: 2 mg) or Vinblastine 6 mg/m2 according to treatment protocol.

Loratadine group

Experimental group

Description:

30 patients will receive One tablet 10 mg orally once daily starting with vincristine or vinblastine administration for three cycles

Treatment:

Drug: Loratadine

diosmin 450mg / hesperidin 50 mg group

Experimental group

Description:

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

Treatment:

Drug: Diosmin/ Hesperidin