Clinical trial · Interventional
Evaluation of Effects of Silymarin on Cisplatin Induced Nephrotoxicity in Upper Gastrointestinal Adenocarcinoma
Phase 2-3 Study of Silymarin on Cisplatin Induced Nephrotoxicity
- 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)
Cisplatin is a potent chemotherapeutic agent that has been widely used to treat many solid tumours. acute renal failure, despite conservative fluid and electrolyte management, frequently reported adverse event and limiting cisplatin use. Silymarin, a flavonolignan complex isolated from Silybum marianum, has a strong antioxidant, hepatoprotective, anticancer and in animal model nephroprotective properties. Neutrophil gelatinase-associated lipocalin (NGAL) protein is a promising biomarker to detect acute kidney injury due to cisplatin. Milk thistle extract inhibitory effects on epidermal growth factor receptor, vascular endothelial growth factor and insulin-like growth factor-I have shown in the previous in-vitro studies.The aim of present study,a randomized double-blind placebo- controlled clinical trial, to investigate the therapeutic effect of silymarin on cisplatin induced nephrotoxicity and it's impact on chemotherapy. Fifty-eight patients with diagnosed upper gastrointestinal tract carcinomas randomized to silymarin (420mg) or placebo plus chemotherapy \[cisplatin 50-60 mg/m2, 5-fluorouracil mg/m2, docetaxel 60-80 mg/m2 every 21 days\] for 63 day after inclusion. serum creatinin, blood urea nitrogen (BUN), serum and urine electrolyte will be measured daily during chemotherapy. changes in urine NGAL, serum vascular endothelial growth factor (VEGF)and caspase activity assessed up to 64 days.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cisplatin Adverse Reaction | — | UNRESOLVED | — |
| Upper GI Cancer | Digestive System Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy | Drug | Chemotherapy | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Silymarin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Control arm
- description
- Placebo 420 mg daily in three divided doses for 65 days as control along with \[cisplatin 50-60mg/m2 + fluorouracil 750 mg/m2 +docetaxel 60-80 mg/m2\]
- interventionNames
- Drug: Placebo
- Drug: chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Exprimental: Silymarin and chemotherapy
- description
- silymarin 420 mg daily in three divided doses for 65 days along with standard chemotherapy \[cisplatin 50-60mg/m2 + fluorouracil 750 mg/m2 +docetaxel 60-80 mg/m2 control
- interventionNames
- Drug: Silymarin
- Drug: chemotherapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * age\>18 years * diagnosed * measurable upper gastrointestinal adenocarcinoma * swallow problem * would like to participate in the study * Glomerular filtration rate(GFR)\>45ml/min/1.73m2 Exclusion Criteria: * end stage renal disease * requiring dialysis * post transplantation * receiving contrast media during last 72 hours * chronic use of corticosteroids * chronic use of angiotensin-converting enzyme inhibitor(ACEI ) * untreated hypo-and hyperthyroidism * ejection fraction\<60% * active urinary tract infection * iver disease ( five fold increase of liver enzyme in asymptomatic or 3 fold increase in symptomatic * use of other nephrotoxic agents such as aminoglycoside, amphotericin * karnofsky performance status \<70
References
Publications (0)
Data not yet available