Breast Cancer, Peripheral Neuropathy
Conditions
Brief summary
At present, there are no FDA-approved treatments for chemotherapy-induced neuropathy. Discrete neuro anti-inflammatory effects of metformin support its repurposing as a neuroprotective agent in patients with neurodegenerative diseases. Therefore, this study aims to evaluate the effect of metformin on the amelioration of paclitaxel induced neuropathy in cancer patients.
Interventions
DRUGMetformin
cidophage 850 gm twice daily
DRUGPlacebo
placebo twice daily for treatment period
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult patients (\>18 years old) * Early-stage breast cancer patients who will receive adjuvant paclitaxel * Performance status according to Eastern Cooperative oncology group (ECOG) \< 2. * Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count ≥100,000/mm3), liver function (serum total bilirubin \<1.5 mg/dl), renal function (creatinine\<1.5 mg/dl).
Exclusion criteria
* Clinical neuropathy at prior to enrollment. * Patients treated with medications that increase the risk of neuropathy like amiodarone, Colchicine, metronidazole, phenytoin. * Patients with a history of hypersensitivity to metformin. * Pregnant or lactating females. * Patients who are using metformin for any other cause. * Patients with Diabetes mellitus. * Receiving vitamin B1, B6, B12 or another vitamin supplemental therapy. * Receiving antidepressants, opioids, adjuvant analgesic agents (eg, anticonvulsants, clonazepam, or mexiletine), topical analgesics, and amifostine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of grade II or more peripheral neuropathy at the end of paclitaxel treatment | 8 weeks | Grading of paclitaxel induced peripheral neuropathy will be done using NCI-CTCAE version (4.03) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to develop grade 2or 3 PIPN | 8 weeks | The time from randomization till development of grade II or III PN will be recorded for all patients included in the study. |
| the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT-GOG-NTX) subscale | 8 weeks | Patient's QOL will be assessed using the validated Arabic version of FACT-GOG-NTX subscale |
| Pain Severity | 8 weeks | The severity of neuropathic pain will be assessed using the Arabic version of the Brief Pain Inventory Short Form (BPI-SF) |
| Serum biomarkers level in (ng/mL) | 8 weeks | Nerve growth factor Biomarkers levels will be measured using commercial ELISA kits. |
Countries
Egypt
Outcome results
None listed