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. * Allocation: Randomized (1:1). * Interventional model: Parallel assignment. * Masking: None (open label).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
50
The intervention under investigation is the administration of oral Alpha-Lipoic Acid (ALA) as an adjunct to standard cisplatin-based chemotherapy.
Minia University Hospital
Minya, Minya Governorate, Egypt
RECRUITINGChange 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
Time frame: Baseline, weekly up to 6 weeks
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
Time frame: Baseline; and end of study (Up to 6 weeks)
Incidence of AKI ain patients receiving cisplatin
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.
Time frame: From cisplatin initiation through end of study (Up to 6 weeks)
Incidence of cisplatin dose reduction, delay, or discontinuation due to nephrotoxicity
Time frame: From cisplatin initiation through end of study (Up to 6 weeks)
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