Clinical trial · Interventional
The Effect of Oral Administration of Hesperidin and Diosmin in Reducing Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients
NCT06811220CI-TRIAL-00085590not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is evaluation of the potential neuroprotective effect of oral hesperidin and diosmin in reducing paclitaxel- induced peripheral neuropathy in the treatment of breast cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hespiridin and Diosmin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Group 1 (Control group): 70 patients will receive Paclitaxel only as neoadjuvant chemotherapy as one
- description
- Patients will receive Paclitaxel only as neoadjuvant chemotherapy as one cycle every 21 days (i.e. 3 weeks) as 175 mg/m2.
- type
- ACTIVE_COMPARATOR
- label
- Group 2 (Intervention group): patients which will receive Paclitaxel plus Hespiridin and Diosmin.
- description
- 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.
- interventionNames
- Drug: Hespiridin and Diosmin
Primary outcomes (4)
- measure
- Changes in serum levels of the following biomarker:Nerve growth factor (NGF)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patients over 18 years of age with pathologically confirmed breast cancer. 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: 1. Patients with signs and symptoms of clinical neuropathy at baseline. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.