The Effect of Oral Administration of Hesperidin and Diosmin in Reducing Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients

Alexandria University

Status and phase: Not yet enrolling; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Hespiridin and Diosmin

Study type: Interventional

Funder types: Other

Identifiers

NCT06811220

0108808

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

140 participants in 2 patient groups

Group 1 (Control group): 70 patients will receive Paclitaxel only as neoadjuvant chemotherapy as one

No Intervention group

Description:

Patients will receive Paclitaxel only as neoadjuvant chemotherapy as one cycle every 21 days (i.e. 3 weeks) as 175 mg/m2.

Group 2 (Intervention group): patients which will receive Paclitaxel plus Hespiridin and Diosmin.

Active Comparator group

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.

Treatment:

Drug: Hespiridin and Diosmin