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

Phase 3Not Yet RecruitingNCT06811220

Alexandria University140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

140

Conditions

Breast Cancer

Interventions

Hespiridin and DiosminDRUG

Daflon® (50 mg Hesperidin and Micronized purified flavonoid fraction (MPFF) 450 diosmin combination one film coated tablet)

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Changes in serum levels of the following biomarker:Nerve growth factor (NGF)

Nerve growth factor (NGF) measured in Pg/ml

Time frame: 3 months

Changes in serum levels of the following biomarker :Malondialdehyde (MDA).

Malondialdehyde (MDA) is measured in Micro mole/L

Time frame: 3 months

Changes in serum levels of the following biomarker:Interleukin-1 beta (IL-1 β).

Interleukin-1 beta (IL-1 β) is measured in Pg/ml

Time frame: 3 months

Changes in serum levels of the following biomarker: Tumor necrosis Factor-Alpha (TNF- α) .

Tumor necrosis Factor-Alpha (TNF- α) is measured in Pg/ml

Time frame: 3 months

Secondary Outcomes

A- Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria assessed.

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.

Time frame: at baseline and after each cycle of neoadjuvant chemotherapy where the length of each cycle is 21 days (i.e. every 21 days).

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.

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.

Central Contacts

Mostafa AE Hassan Mahmoud, Master

CONTACT

03-01148898967 mohassan1869@gmail.com

Data from ClinicalTrials.gov

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