Health TrialsbyHealthPanel

Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity

ConditionsCisplatin NephrotoxicityNephrotoxicity
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMinia University

About this trial

To assess the nephroprotective efficacy of Alpha-Lipoic Acid in preventing cisplatin-induced nephrotoxicity in oncology patients by monitoring renal function changes

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Pre existing renal impairment (eGFR < 60〖" mL/min/1.73 m" 〗²or serum creatinine > 1.5 × upper limit of normal).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Standard HydrationNo intervention 0 interventions
Group B: Alpha Lipoic Acid + Standard HydrationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline, weekly up to 6 weeks

Secondary outcomes

1

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)
2

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)
3

Incidence of cisplatin dose reduction, delay, or discontinuation due to nephrotoxicity

Time frame
From cisplatin initiation through end of study (Up to 6 weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Minia University

Lead sponsor

Minia University Hospital

Collaborator

Source ClinicalTrials.gov
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