NCT01706627

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

Melatonin In Cancer Patients Receiving Chemotherapy: A Randomized, Double Blind, Placebo, Controlled Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Khon Kaen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced Stage Cancer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2007-08-01
• Primary completion: 2011-12-01
• Completion: 2012-06-01
• First posted: 2012-10-15
• Last updated: 2012-10-15

Locations

2 sites across 1 country: Thailand