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

February 2, 2025 updated by: Alexandria University
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group 1 (Control group): 70 patients will receive Paclitaxel only as neoadjuvant chemotherapy as one
Patients will receive Paclitaxel only as neoadjuvant chemotherapy as one cycle every 21 days (i.e. 3 weeks) as 175 mg/m2.
Active Comparator: Group 2 (Intervention group): patients which will receive Paclitaxel plus 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.
Drug: Hespiridin and Diosmin
Daflon® (50 mg Hesperidin and Micronized purified flavonoid fraction (MPFF) 450 diosmin combination one film coated tablet)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in serum levels of the following biomarker:Nerve growth factor (NGF)
Time Frame: 3 months
Nerve growth factor (NGF) measured in Pg/ml
3 months
Changes in serum levels of the following biomarker :Malondialdehyde (MDA).
Time Frame: 3 months
Malondialdehyde (MDA) is measured in Micro mole/L
3 months
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
3 months
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
at baseline and after each cycle of neoadjuvant chemotherapy where the length of each cycle is 21 days (i.e. every 21 days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 27, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 28, 2025

First Submitted That Met QC Criteria

February 2, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 2, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0108808

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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