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NCT Number: NCT06811220

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Hespiridin and Diosmin

Drug

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

Primary outcomes

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

    Time frame: 3 months

    Nerve growth factor (NGF) measured in Pg/ml

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

    Time frame: 3 months

    Malondialdehyde (MDA) is measured in Micro mole/L

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

    Time frame: 3 months

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

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

    Time frame: 3 months

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

Secondary outcomes

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

    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).

    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.

  2. 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.

    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).

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mostafa AE Hassan Mahmoud, Master

CONTACT

[email protected]

03-01148898967

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Feb 6, 2025
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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