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

NCT06811220 | Not Yet Recruiting Phase 3

• 1 other identifier: 0108808
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Breast Cancer

Keywords

Paclitaxel-induced peripheral neuropathy

Outcome Measures

Primary Outcomes (4)

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

  Nerve growth factor (NGF) measured in Pg/ml

  3 months

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

  Malondialdehyde (MDA) is measured in Micro mole/L

  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

  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

  3 months

Secondary Outcomes (2)

• 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).

• 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).

Study Arms (2)

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

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.

Drug: Hespiridin and Diosmin

Interventions

Hespiridin and Diosmin DRUG

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

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female breast cancer patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients over 18 years of age with pathologically confirmed breast cancer.
• Breast cancer patients candidate for chemotherapy and will receive paclitaxel.
• Patients having an eastern cooperative oncology group (ECOG) score more than 2

You may not qualify if:

• Patients with signs and symptoms of clinical neuropathy at baseline.
• Patients with diabetes mellitus, alcoholic disease, heart failure, pregnant or lactating women.
• Patients receiving vitamin/ supplementation drugs that interfere with the study intervention.
• Patients who have previously received chemotherapy.
• Hepatic impaired patients.
• Patient with history of allergy to hesperidin.
• Patients with history of allergy to diosmin.
• Renal impaired patients.
• Patient inadherent to paclitaxel.
• Patients inadherent to the administered hesperidin and diosmin during the study period.

Sponsors & Collaborators

• Alexandria University: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diosmin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Mostafa AE Hassan Mahmoud, Master

CONTACT

03-01148898967; mohassan1869@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 6, 2025
• Study Start: January 27, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 6, 2025

Record last verified: 2025-01