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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (metformin group) | Experimental | who will receive adjuvant paclitaxel in addition to metformin tablets (1700 mg daily) during the chemotherapy treatment duration. |
|
| Group II (control group) | Placebo Comparator | who will receive adjuvant weekly paclitaxel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | cidophage 850 gm twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of grade II or more peripheral neuropathy at the end of paclitaxel treatment | Grading of paclitaxel induced peripheral neuropathy will be done using NCI-CTCAE version (4.03) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to develop grade 2or 3 PIPN | The time from randomization till development of grade II or III PN will be recorded for all patients included in the study. | 8 weeks |
| the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT-GOG-NTX) subscale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University | Al Mansurah | 35516 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37583905 | Derived | Bakry HM, Mansour NO, ElKhodary TR, Soliman MM. Efficacy of metformin in prevention of paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled trial. Front Pharmacol. 2023 Jul 31;14:1181312. doi: 10.3389/fphar.2023.1181312. eCollection 2023. |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Placebo |
| Drug |
placebo twice daily for treatment period |
|
Patient's QOL will be assessed using the validated Arabic version of FACT-GOG-NTX subscale |
| 8 weeks |
| Pain Severity | The severity of neuropathic pain will be assessed using the Arabic version of the Brief Pain Inventory Short Form (BPI-SF) | 8 weeks |
| Serum biomarkers level in (ng/mL) | Nerve growth factor Biomarkers levels will be measured using commercial ELISA kits. | 8 weeks |
| D001941 |
| Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |