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

NCT06811220 — Phase 3, Not yet recruiting, 140 participants, Alexandria University

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Registry	NCT06811220
Status	Not yet recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	140 (Estimated)
Sponsor	Alexandria University (Other)
Conditions	Breast Cancer
Interventions	Hespiridin and Diosmin (Drug)
Dates	start 2025-01-27 (estimated), primary completion 2025-12-31 (estimated), completion 2027-12-31 (estimated), first posted 2025-02-06, last updated 2025-02-06

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Group 1 (Control group): 70 patients will receive Paclitaxel only as neoadjuvant chemotherapy as one	No intervention		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	Drug: 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 (Drug): Daflon® (50 mg Hesperidin and Micronized purified flavonoid fraction (MPFF) 450 diosmin combination one film coated tablet)

+Outcome measures

Primary outcomes

Changes in serum levels of the following biomarker:Nerve growth factor (NGF) [3 months]: Nerve growth factor (NGF) measured in Pg/ml
Changes in serum levels of the following biomarker :Malondialdehyde (MDA). [3 months]: Malondialdehyde (MDA) is measured in Micro mole/L
Changes in serum levels of the following biomarker:Interleukin-1 beta (IL-1 β). [3 months]: Interleukin-1 beta (IL-1 β) is measured in Pg/ml
Changes in serum levels of the following biomarker: Tumor necrosis Factor-Alpha (TNF- α) . [3 months]: Tumor necrosis Factor-Alpha (TNF- α) is measured in Pg/ml

Secondary outcomes

A- Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria assessed. [at baseline and after each cycle of neoadjuvant chemotherapy where the length of each cycle is 21 days (i.e. every 21 days).]: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria ; where its classified as mild, moderate and severe peripheral neuropathy according to severity of subjective peripheral neuropathy reported by the patient.
B- Measurement of the quality of life using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity FACT/GOG-NTX (Version 4) questionnaire assessed. [at baseline and after each cycle of neoadjuvant chemotherapy where the length of each cycle is 21 days (i.e. every 21 days).]: Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity FACT/GOG-NTX (Version 4) questionnaire where the minumum score is zero and the maximum score is 16. The higher the score the better the quality of life.

+Eligibility

Sex: Female, ages: 18 Years to any

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.