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

NCT01706627 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2012-10-15

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Srinagarind Hospital, Khon Kaen University

    collaborator OTHER

  • Khon Kaen Hospital, Khon Kaen

    collaborator UNKNOWN

  • General Drugs House Co.,LTD.

    collaborator OTHER

  • Thailand Research Fund

    collaborator OTHER

  • Khon Kaen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2011-12-31
Completion
2012-06-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01706627 on ClinicalTrials.gov