Evaluating protective and therapeutic effects of alpha-lipoic acid on cisplatin-induced ototoxicity.
Kyung-Hee Kim, Byeonghyeon Lee, Ye-Ri Kim...
https://pubmed.ncbi.nlm.nih.gov/30068942Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID07564479
Evaluation of Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity in Oncology Patients
Led by Minia University · Updated on 2026-05-04
50
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
M
Minia University
Lead Sponsor
M
Minia University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the potential protective effect of Alpha-Lipoic Acid (ALA) against kidney damage caused by cisplatin chemotherapy in patients with solid tumors. This proof-of-concept, randomized, controlled, open-label clinical trial aims to assess changes in kidney function when ALA is added to standard preventive care during cisplatin treatment. The study is sponsored by Minia University and focuses on monitoring kidney health in oncology patients receiving cisplatin-based regimens. Participants are randomly assigned to one of two groups. Both groups receive standard preventive measures such as hydration, antiemetics, and mineral supplementation. The experimental group also takes oral Alpha-Lipoic Acid twice daily, starting two days before the first cisplatin dose and continuing throughout each chemotherapy cycle, for up to four cycles. The control group receives only standard preventive care alongside their chemotherapy. During the study, researchers monitor kidney function weekly for up to six weeks, assessing serum creatinine and creatinine clearance levels. They also evaluate patients' quality of life and track occurrences of acute kidney injury, as well as any cisplatin dose changes due to kidney issues. Participants are followed closely throughout the treatment period to gather data on kidney health and safety outcomes related to the addition of ALA.
CONDITIONS
Brief Title
Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed solid malignancy
- Planned treatment with cisplatin starting at a dose of 60 mg/m2 per cycle (21-28 days each or fractionated)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Baseline serum creatinine within normal range or estimated glomerular filtration rate (eGFR) of 60 mL/min/1.73 m2 or higher
- Ability to provide informed consent
You will not qualify if you...
- Pre-existing renal impairment (eGFR below 60 mL/min/1.73 m2 or serum creatinine greater than 1.5 times the upper limit of normal)
- Use of known nephrotoxic drugs that cannot be stopped (e.g., aminoglycosides, amphotericin B, high dose NSAIDs)
- Uncontrolled hypertension
- Decompensated heart failure
- Severe hepatic impairment
- Known allergy or intolerance to Alpha-Lipoic Acid
- Pregnancy or breastfeeding
- Participation in another interventional clinical trial
AI-Screening
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1
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 6 weeks
Participants receive cisplatin-based chemotherapy with standard preventive measures. Those in the experimental group also take oral Alpha-Lipoic Acid starting 2 days before the first cisplatin dose and continuing through each chemotherapy cycle for a total of 4 cycles.
Weekly visits during chemotherapy cycles
Trial Site Locations
Total: 1 location
1
Minia University Hospital
Minya, Minya Governorate, Egypt, 61111
Actively Recruiting
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Research Team
A
Asmaa Mohammed
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Alpha lipoic acid exerts antioxidant effect via Nrf2/HO-1 pathway activation and suppresses hepatic stellate cells activation induced by methotrexate in rats.
Ahmed M Fayez, Soad Zakaria, Dina Moustafa
https://pubmed.ncbi.nlm.nih.gov/29879626Safety and Efficacy of Alpha Lipoic Acid During 4 Years of Observation: A Retrospective, Clinical Trial in Healthy Subjects in Primary Prevention.
Giuseppe Derosa, Angela D'Angelo, Paola Preti...
https://pubmed.ncbi.nlm.nih.gov/33299302Efficacy 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.
Anand Rajeswaran, Andreas Trojan, Bernard Burnand...
https://pubmed.ncbi.nlm.nih.gov/17720276