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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hespiridin and Diosmin | Drug | Daflon® (50 mg Hesperidin and Micronized purified flavonoid fraction (MPFF) 450 diosmin combination one film coated tablet) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Female breast cancer patients
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mostafa AE Hassan Mahmoud, Master | Contact | 03-01148898967 | mohassan1869@gmail.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D004145 | Diosmin |
| ID | Term |
|---|---|
| D047309 | Flavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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| 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. | at baseline and after each cycle of neoadjuvant chemotherapy where the length of each cycle is 21 days (i.e. every 21 days). |
| D017437 |
| Skin and Connective Tissue Diseases |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |