Cisplatin Nephrotoxicity, Nephrotoxicity
Conditions
Keywords
Cisplatin, Nephrotoxicity, ALA, Alpha-Lipoic Acid
Brief summary
To assess the nephroprotective efficacy of Alpha-Lipoic Acid in preventing cisplatin-induced nephrotoxicity in oncology patients by monitoring renal function changes
Detailed description
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).
Interventions
The intervention under investigation is the administration of oral Alpha-Lipoic Acid (ALA) as an adjunct to standard cisplatin-based chemotherapy.
Sponsors
Minia University
Minia University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. Histologically confirmed solid malignancy. Planned treatment with cisplatin starting from a dose of 60 mg/m2 per cycle (21-28 days each or fractionated). 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
* Pre existing renal impairment (eGFR \< 60〖" mL/min/1.73 m" 〗\^2or serum creatinine \> 1.5 × upper limit of normal). 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in SCr and CrCl in patients receiving Cisplatin Chemotherapy + Alpha-Lipoic Acid compared to Control Group | Baseline, weekly up to 6 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients' Quality of Life | Baseline; and end of study (Up to 6 weeks) | 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 |
| Incidence of AKI ain patients receiving cisplatin | From cisplatin initiation through end of study (Up to 6 weeks) | 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. |
| Incidence of cisplatin dose reduction, delay, or discontinuation due to nephrotoxicity | From cisplatin initiation through end of study (Up to 6 weeks) | — |
Countries
Egypt
Contacts
CONTACTAsmaa Mohammed
STUDY_DIRECTORAhmed Mostafa Abd-Elaziz
Department of Clinical Oncology, Faculty of Medicine, Minia University
STUDY_CHAIRAmal Kamal Hussein
Faculty of Pharmacy, Minia University
STUDY_DIRECTOREman Mohamed Sadek
Faculty of Pharmacy, Minia University
PRINCIPAL_INVESTIGATORAsmaa Basem Mohammed
Faculty of Pharmacy, Minia University
Outcome results
None listed