Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Minia University Hospital | OTHER |
Not provided
Not provided
Not provided
To assess the nephroprotective efficacy of Alpha-Lipoic Acid in preventing cisplatin-induced nephrotoxicity in oncology patients by monitoring renal function changes
This proof-of-concept study will be a randomized, controlled, open label clinical trial with parallel group assignment, designed to evaluate the nephroprotective effect of alpha lipoic acid (ALA) in patients receiving cisplatin based chemotherapy.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Hydration | No Intervention | o Standard preventive measures for cisplatin nephrotoxicity (e.g., pre and post hydration, antiemetics, magnesium and potassium supplementation as per unit protocol) will be applied. | |
| Alpha Lipoic Acid + Standard Hydration | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpha-Lipoic Acid (ALA) | Drug | The intervention under investigation is the administration of oral Alpha-Lipoic Acid (ALA) as an adjunct to standard cisplatin-based chemotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in SCr and CrCl in patients receiving Cisplatin Chemotherapy + Alpha-Lipoic Acid compared to Control Group | Measuring the change in Scr and CrCl in patients before and after they have a cumulative dose of 200mg/m2, depending on each patient's dosage regimen | Baseline, weekly up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' Quality of Life | We will measure the patients' quality of life using the Arabic version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) questionnaire | Baseline; and end of study (Up to 6 weeks) |
| Incidence of AKI ain patients receiving cisplatin |
Not provided
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Baseline serum creatinine within normal range or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2.
Ability to provide informed consent.
Exclusion Criteria:
Concomitant use of known nephrotoxic drugs that cannot be stopped (e.g., aminoglycosides, amphotericin B, high dose NSAIDs).
Uncontrolled hypertension, decompensated heart failure, or severe hepatic impairment.
Known allergy or intolerance to ALA. Pregnancy or lactation. Participation in another interventional clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asmaa Mohammed | Contact | 00201090824147 | asmaa.bashandy@mu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed Mostafa Abd-Elaziz | Department of Clinical Oncology, Faculty of Medicine, Minia University | Study Director |
| Amal Kamal Hussein | Faculty of Pharmacy, Minia University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minia University Hospital | Recruiting | Minya | Minya Governorate | 61111 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30068942 | Background | Kim KH, Lee B, Kim YR, Kim MA, Ryu N, Jung DJ, Kim UK, Baek JI, Lee KY. Evaluating protective and therapeutic effects of alpha-lipoic acid on cisplatin-induced ototoxicity. Cell Death Dis. 2018 Aug 1;9(8):827. doi: 10.1038/s41419-018-0888-z. | |
| 29879626 | Background | Fayez AM, Zakaria S, Moustafa D. Alpha lipoic acid exerts antioxidant effect via Nrf2/HO-1 pathway activation and suppresses hepatic stellate cells activation induced by methotrexate in rats. Biomed Pharmacother. 2018 Sep;105:428-433. doi: 10.1016/j.biopha.2018.05.145. Epub 2018 Jun 5. |
Not provided
Not provided
To protect the privacy of participants as the sample size is small and in one location
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008063 | Thioctic Acid |
| ID | Term |
|---|---|
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
AKI is defined as o An increase in serum creatinine ≥ 0.3 mg/dL within 48 hours or ≥ 1.5 times baseline within 7 days; or o A decrease in eGFR ≥ 25% from baseline; according to KDIGO acute kidney injury criteria. |
| From cisplatin initiation through end of study (Up to 6 weeks) |
| Incidence of cisplatin dose reduction, delay, or discontinuation due to nephrotoxicity | From cisplatin initiation through end of study (Up to 6 weeks) |
| Eman Mohamed Sadek |
| Faculty of Pharmacy, Minia University |
| Study Director |
| Asmaa Basem Mohammed | Faculty of Pharmacy, Minia University | Principal Investigator |
| 33299302 | Background | Derosa G, D'Angelo A, Preti P, Maffioli P. Safety and Efficacy of Alpha Lipoic Acid During 4 Years of Observation: A Retrospective, Clinical Trial in Healthy Subjects in Primary Prevention. Drug Des Devel Ther. 2020 Dec 3;14:5367-5374. doi: 10.2147/DDDT.S280802. eCollection 2020. |
| 17720276 | Background | Rajeswaran A, Trojan A, Burnand B, Giannelli M. Efficacy and side effects of cisplatin- and carboplatin-based doublet chemotherapeutic regimens versus non-platinum-based doublet chemotherapeutic regimens as first line treatment of metastatic non-small cell lung carcinoma: a systematic review of randomized controlled trials. Lung Cancer. 2008 Jan;59(1):1-11. doi: 10.1016/j.lungcan.2007.07.012. Epub 2007 Aug 27. |
| D003067 |
| Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |