Vinca Alkaloid Adverse ReactionPhase 3NCT05243706
Evaluation of The Effect of Loratadine Versus Diosmin/Hesperidin Combination on Vinca Alkaloids Induced Neuropathy
A Phase 3 study testing Loratadine and Diosmin/ Hesperidin in people with Vinca Alkaloid Adverse Reaction, run by Ain Shams University.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vinca Alkaloid Adverse Reaction
- What is being tested?
- Loratadine and Diosmin/ Hesperidin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 30 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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 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.
- Conditions
- Vinca Alkaloid Adverse Reaction
- Being tested
- Loratadine, Diosmin/ Hesperidin
- Keywords
- neuropathy, Vinca alkaloids, Diosmin/Hespridin, Loratadine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoratadineDrug
Intervention is given to study its' effect on vinca alkaloids induced neuropathy
Diosmin/ HesperidinDrug
Intervention is given to study its effect on vinca alkaloids induced neuropathy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Diosmin/ Hesperidin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measure the time of neuropathy onset in patients
Measured: 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)
Measured: from baseline to after Three cycles of vinca alkaloids (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start1 Mar 2022 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vinca Alkaloid Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Kamal Morsy Ibraheem, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243706
- Sponsor's protocol ID
- AinShamsU2
- Status last verified
- Feb 2022
- First submitted
- 22 Jan 2022
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Effect of Loratadine Versus Diosmin/Hesperidin Combination on Vinca Alkaloids Induced Neuropathy
- ClinicalTrials.gov ID
- NCT05243706
- Acronym / sponsor ID
- AinShamsU2
- Conditions
- Vinca Alkaloid Adverse Reaction
- Keywords
- neuropathy, Vinca alkaloids, Diosmin/Hespridin, Loratadine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Loratadine30 patients will receive One tablet 10 mg orally once daily starting with vincristine or vinblastine administration for three cycles |
| diosmin 450mg / hesperidin 50 mg group | Experimental | Drug: Diosmin/ Hesperidin30 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LoratadineIntervention is given to study its' effect on vinca alkaloids induced neuropathy | Drug | Loratadine group |
| Diosmin/ HesperidinIntervention is given to study its effect on vinca alkaloids induced neuropathy | Drug | diosmin 450mg / hesperidin 50 mg group |
Primary outcome
Assessing the efficacy of loratadine or diosmin 450mg/ hesperidin 50 mg on neuropathy pain intensity of Vinca alkaloids neuropathy compared to routine practice.
Time frame: At baseline and after three cycles of vinca alkaloids (each cycle is 28 days)
Measure of average pain intensity assessed by Numeric Pain Rating Scale (NS) change from baseline to after three cycles of vinca alkaloids therapy
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.
Time frame: At baseline and after three cycles of vinca alkaloids (each cycle is 28 days)
Neuropathic Pain in 4 questions (DN4) change from baseline to after three cycles of vinca alkaloids therapy
Assessing the efficacy of loratadine or diosmin 450mg/ hesperidin 50 mg on symptoms of peripheral neuropathy of Vinca alkaloids compared to routine practice.
Time frame: At baseline and after three cycles of vinca alkaloids (each cycle is 28 days)
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) change from baseline to after three cycles of vinca alkaloids therapy
Assessing the efficacy of loratadine or diosmin 450mg/ hesperidin 50 mg on development of Vinca alkaloids neuropathy compared to routine practice.
Time frame: At baseline and after three cycles of vinca alkaloids (each cycle is 28 days)
Measuring Peripheral blood Neurofilament Proteins and IL-1 beta change from baseline to after three cycles of vinca alkaloids therapy
2 secondary outcomes
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.
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
Time frame: from baseline to after Three cycles of vinca alkaloids (each cycle is 28 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Loratadine and Diosmin/ Hesperidin in people with Vinca Alkaloid Adverse Reaction, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noha Kamal Morsy Ibraheem, Assistant lecturer (+201002014552, noha2010_pharma@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the efficacy of loratadine or diosmin 450mg/ hesperidin 50 mg on neuropathy pain intensity of Vinca alkaloids neuropathy compared to routine practice. (time frame: At baseline and after three cycles of vinca alkaloids (each cycle is 28 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.