The Effect of Oral Administration of Hesperidin and Diosmin in Reducing Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients
NCT ID: NCT06811220
Last Updated: 2025-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
140 participants
INTERVENTIONAL
2025-01-27
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group 1 (Control group): 70 patients will receive Paclitaxel only as neoadjuvant chemotherapy as one
Patients will receive Paclitaxel only as neoadjuvant chemotherapy as one cycle every 21 days (i.e. 3 weeks) as 175 mg/m2.
No interventions assigned to this group
Group 2 (Intervention group): patients which will receive Paclitaxel plus Hespiridin and Diosmin.
patients which will receive Paclitaxel plus Daflon® (50 mg Hesperidin and Micronized purified flavonoid fraction (MPFF) 450 diosmin combination one film coated tablet) 2 tablets daily, i.e. 1 tablet at midday and 1 tablet in the evening, at meal times.
Hespiridin and Diosmin
Daflon® (50 mg Hesperidin and Micronized purified flavonoid fraction (MPFF) 450 diosmin combination one film coated tablet)
Interventions
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Hespiridin and Diosmin
Daflon® (50 mg Hesperidin and Micronized purified flavonoid fraction (MPFF) 450 diosmin combination one film coated tablet)
Eligibility Criteria
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Inclusion Criteria
2. Breast cancer patients candidate for chemotherapy and will receive paclitaxel.
3. Patients having an eastern cooperative oncology group (ECOG) score more than 2
Exclusion Criteria
2. Patients with diabetes mellitus, alcoholic disease, heart failure, pregnant or lactating women.
3. Patients receiving vitamin/ supplementation drugs that interfere with the study intervention.
4. Patients who have previously received chemotherapy.
5. Hepatic impaired patients.
6. Patient with history of allergy to hesperidin.
7. Patients with history of allergy to diosmin.
8. Renal impaired patients.
9. Patient inadherent to paclitaxel.
10. Patients inadherent to the administered hesperidin and diosmin during the study period.
18 Years
FEMALE
No
Sponsors
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Alexandria University
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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0108808
Identifier Type: -
Identifier Source: org_study_id
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