Clinical trial · Interventional
Clinical Effects of Alpha-Lipoic Acid in Advanced NSCLC
The Effect of Alpha Lipoic Acid on the Clinical Outcome of Advanced Non-Small Cell Lung Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Non-small cell lung cancer (NSCLC) is a common and aggressive type of lung cancer often diagnosed at advanced stages, with limited treatment options and poor prognosis. Oxidative stress, inflammation, and dysregulated signaling pathways contribute to tumor progression, metastasis, and chemotherapy resistance. Alpha-lipoic acid (ALA), a potent antioxidant with anti-inflammatory properties, has shown promise in preclinical and early clinical studies by reducing oxidative stress, enhancing chemotherapy efficacy, and improving immune response. The aim of this study is to evaluate the clinical effect and safety of oral ALA (600 mg daily) in combination with standard platinum-based chemotherapy in patients with advanced non-resectable Stage III or IV NSCLC. Primary outcomes include clinical benefit and tumor response, while secondary outcomes include 1-year progression-free survival, 1-year overall survival, chemotherapy toxicity, and quality of life.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Non Small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alpha Lipoic Acid 600mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- intervention group
- description
- 30 patients will receive oral Alpha Lipoic Acid 600 mg once daily in addition to platinum doublet for 6-8 cycles
- interventionNames
- Drug: Alpha Lipoic Acid 600mg
- type
- NO_INTERVENTION
- label
- control group
- description
- 30 patients will receive platinum doublet for 6-8 cycles
Primary outcomes (2)
- measure
- 1. Clinical Benefit Rate (CBR)
- timeFrame
- 1 year
- description
- Proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1 criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (\>18 years old). * Non-respectable Stage III and IV NSCLC. * Patients ECOG PS of 0-2. * With no-actionable or unknown driver mutation * Planned to receive platinum doublets with or without immune checkpoint inhibitors. * Adequate organ function defined as; Absolute neutrophil count of more than 1.5×109 cells per L, more than 100×109 platelets per L, conjugated bilirubin serum concentration of up to 1.5 times the upper limit of normal, serum concentrations of alkaline phosphatase and aminotransferases of up to 2.5 times the upper limit of normal, and creatinine clearance of more than 60 mL/ min. Exclusion Criteria: * History of hypersensitivity to alpha lipoic acid. * Pregnancy or lactation. * patients receiving medications that interact with alpha lipoic acid, such as: * Iron supplements * Thyroid medications * Patients with severe cognitive impairments, neurological disorders (e.g., dementia, Alzheimer's disease), or severe psychiatric conditions that would interfere with the ability to comply with study protocols or follow-up * Uncontrolled heart disease (e.g., recent myocardial infarction, congestive heart failure) * Severe hypertension not controlled by medication * Patients with brain metastases.
References
Publications (1)
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