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

NCT05243706 | Unknown Phase 3

• 1 other identifier: AinShamsU2
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Vinca Alkaloid Adverse Reaction

Keywords

neuropathy; Vinca alkaloids; Diosmin/Hespridin; Loratadine

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  At baseline and after three cycles of vinca alkaloids (each cycle is 28 days)

Secondary Outcomes (2)

• 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.

  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

  from baseline to after Three cycles of vinca alkaloids (each cycle is 28 days)

Study Arms (3)

Control group

NO INTERVENTION

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

Loratadine group

EXPERIMENTAL

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

Drug: Loratadine

diosmin 450mg / hesperidin 50 mg group

EXPERIMENTAL

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

Interventions

Loratadine DRUG

Intervention is given to study its' effect on vinca alkaloids induced neuropathy

Loratadine group

Diosmin/ Hesperidin DRUG

Intervention is given to study its effect on vinca alkaloids induced neuropathy

diosmin 450mg / hesperidin 50 mg group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Interventions

Loratadine; Diosmin; Hesperidin

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Flavanones; Glycosides; Carbohydrates

Central Study Contacts

Noha Kamal Morsy Ibraheem, Assistant lecturer

CONTACT

+201002014552; noha2010_pharma@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer at faculty of Pharmacy, University of Sadat City

Study Record Dates

• First Submitted: January 22, 2022
• First Posted: February 17, 2022
• Study Start: March 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: December 30, 2023
• Last Updated: February 17, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share