Trial | NCT01706627  Report issue

Title

Melatonin In Reduction of Chemotherapy-Induced Toxicity (MIRCIT) Trial
Melatonin In Cancer Patients Receiving Chemotherapy: A Randomized, Double Blind, Placebo, Controlled Trial

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    melatonin ...

  • Study Participants

    175
Meta-analysis of previous studies have shown that melatonin is a beneficial adjutant for reducing chemotherapy-induced toxicity; however no randomized, double-blind, placebo controlled trials have been conducted. This study evaluates the effect of melatonin in improving quality of life and reducing chemotherapy-induced toxicity in advanced cancer patients. This is a multi-center, randomized, double-blind, placebo controlled trial conducted in patients with histologically proven advanced non small cell lung, breast, head and neck or sarcoma cancer. Mixed-block randomization, stratified by center and treatment scheme is used to divide eligible patients into three groups: melatonin 20 mg, 10 mg or matched placebo. The patients are required to take the studied drugs at night (after 21.00 pm) on the first day of chemotherapy and continue daily for six months. Standard treatment is chemotherapy according to each center's standard protocol. Study endpoints are QOL (FACT), adverse event frequency (CTCAE), oxidative stress status, melatonin level, and survival.
Study Started
Aug 31
2007
Primary Completion
Dec 31
2011
Study Completion
Jun 30
2012
Last Update
Oct 15
2012
Estimate

Drug 10 mg Melatonin

Active Comparator: Drug: Melatonin 10 mg

Drug 20 mg Melatonin

Active Comparator: Drug: Melatonin 20 mg

Drug Matched placebo

Matched placebo (identical formulation and delivery, without active ingredient)

Matched placebo Placebo Comparator

Matched placebo (identical formulation and delivery, without active ingredient)

Drug: 10 mg Melatonin Active Comparator

10 mg melatonin gelatin capsule

Drug: 20 mg Melatonin Active Comparator

20 mg melatonin gelatin capsule

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).
No Results Posted