Melatonin In Reduction of Chemotherapy-Induced Toxicity (MIRCIT) Trial

Launched by KHON KAEN UNIVERSITY · Oct 11, 2012

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • histologically proven advanced NSCLC, breast, head and neck, sarcoma cancer Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
• • platelet count ≥100,000 cells/mm3
• • white blood cell count ≥ 3,000 cell/mm3
• • hemoglobin ≥ 10 g/dL
• • serum creatinine ≤ 1.5 mg/dL
• • bilirubin ≤ 2 mg/dL
• • AST ≤ 2.5 times upper limit of normal(ULN)for subjects without metastases or AST ≤ 2.5 times UNL for those with liver metastases
• • New York Heart Association grade ≤ 2
• • written consent
• Exclusion Criteria:
• • Patients who receive prior chemotherapy or biotherapy, radiotherapy or surgery within 1 month preceding randomization
• • Patients who have more than one type of cancer or brain metastasis were excluded from the trial.
• • Patients with moderate neuropathy (CTCAE grade ≥ 2)
• • Patients with an active infection, or uncontrolled complications (i.e. blood glucose \> 200 mg/dL, uncontrolled hypertension, unstable angina, history of congestive heart failure or history of myocardial infarction within one year).