Breast Cancer
Conditions
Keywords
Paclitaxel-induced peripheral neuropathy
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.
Interventions
DRUGHespiridin and Diosmin
Daflon® (50 mg Hesperidin and Micronized purified flavonoid fraction (MPFF) 450 diosmin combination one film coated tablet)
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in serum levels of the following biomarker:Nerve growth factor (NGF) | 3 months | Nerve growth factor (NGF) measured in Pg/ml |
| Changes in serum levels of the following biomarker :Malondialdehyde (MDA). | 3 months | Malondialdehyde (MDA) is measured in Micro mole/L |
| Changes in serum levels of the following biomarker:Interleukin-1 beta (IL-1 β). | 3 months | Interleukin-1 beta (IL-1 β) is measured in Pg/ml |
| Changes in serum levels of the following biomarker: Tumor necrosis Factor-Alpha (TNF- α) . | 3 months | Tumor necrosis Factor-Alpha (TNF- α) is measured in Pg/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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. |
| 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). | 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. |
Contacts
Primary ContactMostafa AE Hassan Mahmoud, Master
Outcome results
None listed