Not yet recruiting NCT06811220
The Effect of Oral Administration of Hesperidin and Diosmin in Reducing Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hespiridin and Diosmin.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Drug Hespiridin and Diosmin
Daflon® (50 mg Hesperidin and Micronized purified flavonoid fraction (MPFF) 450 diosmin combination one film coated tablet)
Primary outcome measures
- Changes in serum levels of the following biomarker:Nerve growth factor (NGF) [Time frame: 3 months]
- Changes in serum levels of the following biomarker :Malondialdehyde (MDA). [Time frame: 3 months]
- Changes in serum levels of the following biomarker:Interleukin-1 beta (IL-1 β). [Time frame: 3 months]
- Changes in serum levels of the following biomarker: Tumor necrosis Factor-Alpha (TNF- α) . [Time frame: 3 months]
Secondary outcome measures (2)
- 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).]
- 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).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06811220 · 0108808