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| Name | Class |
|---|---|
| German University in Cairo | OTHER |
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Chemotherapy cause many adverse events including induction of peripheral neuropathy. Metformin, the AMPK activator, was found to have protective effect against chemotherapy induced peripheral neuropathy in mouse model and in clinical trials as well. There are different hypothesized mechanisms through which metformin does the protective effect. Such as enhancing mitochondrial activity, reduction of ROS and nitric oxide and activation of AMPK.
Chemotherapy can cause a variety of side effects. One of the most common side effects is Chemotherapy induced peripheral neuropathy (CIPN), it commonly caused by Paclitaxel chemotherapy which is usually used in the treatment of breast cancer. Metformin which is known as a safe anti-diabetic drug, was found to have a protective effect on neurons. It gave positive results in chemotherapy induced peripheral neuropathy in mouse models and in some clinical trials
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin group | Active Comparator | 1 gm metformin tablet administered twice daily for 3 months |
|
| Metformin-free | Placebo Comparator | 1 placebo tablet administered twice daily for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Participants in the intervention group will be administered metformin tablets 2 gm daily during the chemotherapy treatment duration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of grade 2-4 neurotoxicity in both arms | Measured by NCI-CTCAE system | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in biological markers in both arms. | Measurement of Nerve growth factor (NGF) | 3 months |
| Difference in biological markers in both arms. | Measurement of Malondialdehyde (MDA) |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara A. Mosa, Bsc | Contact | +201008662223 | sara.araby96@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed H. Solayman, PhD. Pharm. | German University in Cairo | Study Chair |
| Loay M. Kassem, PhD | Cairo University | Principal Investigator |
| Danira Ashraf Habashy, PhD Pharm. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30139229 | Background | Gaballah A, Shafik A, Elhusseiny K, Ashraf M. Chemotherapy-Induced Peripheral Neuropathy in Egyptian Patients: Single Institution Retrospective Analysis. Asian Pac J Cancer Prev. 2018 Aug 24;19(8):2223-2227. doi: 10.22034/APJCP.2018.19.8.2223. | |
| 24955774 | Background | Mao-Ying QL, Kavelaars A, Krukowski K, Huo XJ, Zhou W, Price TJ, Cleeland C, Heijnen CJ. The anti-diabetic drug metformin protects against chemotherapy-induced peripheral neuropathy in a mouse model. PLoS One. 2014 Jun 23;9(6):e100701. doi: 10.1371/journal.pone.0100701. eCollection 2014. |
| Label | URL |
|---|---|
| Pathophysiology of Chemotherapy-Induced Peripheral Neuropathy. | View source |
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| ID | Term |
|---|---|
| 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 | Participants in the placebo group will be administered metformin free tablet as placebo twice daily |
|
|
| 3 months |
| Percentage of Qulaity of Life (QOL) deterioration in both arms | Measured using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) questionnaire. The higher the score, the better the quality of life. | 3 months |
| Percentage of other treatment related common adverse events in both arms. | Graded using NCI-CTCAE system | 3 months |
| German University in Cairo |
| Principal Investigator |
| Sara A. Mosa, Bsc | German University in Cairo | Principal Investigator |
| 24733808 | Result | Hershman DL, Lacchetti C, Dworkin RH, Lavoie Smith EM, Bleeker J, Cavaletti G, Chauhan C, Gavin P, Lavino A, Lustberg MB, Paice J, Schneider B, Smith ML, Smith T, Terstriep S, Wagner-Johnston N, Bak K, Loprinzi CL; American Society of Clinical Oncology. Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014 Jun 20;32(18):1941-67. doi: 10.1200/JCO.2013.54.0914. Epub 2014 Apr 14. |