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Spots Global Cancer Trial Database for Melatonin In Reduction of Chemotherapy-Induced Toxicity (MIRCIT) Trial

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Trial Identification

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

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

Study ID: NCT01706627

Study Description

Brief 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Khon Kaen Hospital, Khon Kaen, , Thailand

Srinagarind Hospital, Khon Kaen, , Thailand

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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