Condition 1: oesophagus cancer. Condition 2: Stomach Cancer. Malignant neoplasm of oesophagus Malignant neoplasm of stomach
Conditions
Interventions
Intervention 1: silymarin 420 mg daily in three divided doses for 65 days along with standard chemotherapy [cisplatin 50-60mg/m2 +5-FU 750 mg/m2 +docetaxel 60-80 mg/m2 control]. Intervention 2: plac
Treatment - Drugs
Placebo
silymarin 420 mg daily in three divided doses for 65 days along with standard chemotherapy [cisplatin 50-60mg/m2 +5-FU 750 mg/m2 +docetaxel 60-80 mg/m2 control]
placebo 420 mg daily in three divided doses for 65 days as control along with chemotherapy same as intervention
Sponsors
tehran university of medical science,
Eligibility
Sex/Gender
All
Age
18 Years to 139 Years
Inclusion criteria
Inclusion criteria: inclusion criteria (age>18 years; diagnosed and measurale upper gasterointestinal adenocarcinoma; no swallow problem; would like to participate in the study; 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 ACEI; untreated hypo-and hyperthyroidism; ejection fraction<60%; active urinary tract infection; iver disease (5fold increase of liver enzyme in asymptomatic or 3 fold increase in syptomatic; ; use of other nephrotoxic agents such as aminoglycoside, amphotricin; karnofsky performance status <70)
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine neutrophil gelatinase-associated lipocalin (NGAL). Timepoint: before chemotherapy and at 6,24 hours after first and third cycle of chemotherapy, day 21 before second cycle. Method of measurement: ELISA kit.;Serum concentration of VEGF and tissue activity of caspase 3. Timepoint: after recruitment and the end of study after three chemotherapy cycle. Method of measurement: ELISA kit. | — |
Countries
Iran (Islamic Republic of)
Outcome results
None listed