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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01706627
Recruitment Status : Completed
First Posted : October 15, 2012
Last Update Posted : October 15, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Advanced Stage Cancer Drug: 10 mg Melatonin Drug: 20 mg Melatonin Drug: Matched placebo Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Melatonin In Cancer Patients Receiving Chemotherapy: A Randomized, Double Blind, Placebo, Controlled Trial
Study Start Date : August 2007
Primary Completion Date : December 2011
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Matched placebo
Matched placebo (identical formulation and delivery, without active ingredient)
Drug: Matched placebo
Matched placebo (identical formulation and delivery, without active ingredient)
Active Comparator: Drug: 10 mg Melatonin
10 mg melatonin gelatin capsule
Drug: 10 mg Melatonin
Active Comparator: Drug: Melatonin 10 mg
Active Comparator: Drug: 20 mg Melatonin
20 mg melatonin gelatin capsule
Drug: 20 mg Melatonin
Active Comparator: Drug: Melatonin 20 mg

Outcome Measures

Primary Outcome Measures :
  1. Quality of Life (FACT) [ Time Frame: Change from baseline in total scores at 6 months after treatment ]
    Self-reported questionnaires. FACT-L, FACT-B, FACT-H&N and FACT-G Thai Version 4 has been previously validated. FACT-L, FACT-B, FACT-H&N and FACT-G are used in lung, breast, head&neck and sarcoma cancer patients, respectively. Change from baseline will be evaluated at 1,2,3 and 6 months after treatment.

Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Baseline and 1,2,3 and 6 months after treatment ]
    CTCAE Version 4.3

  2. Oxidative stress status [ Time Frame: Chemotherapy cycles 1,2,3,4 ]
    8-isoprostane and 8-hydroxydeoxyguanosine urine and MDA plasma analysis

  3. Melatonin level [ Time Frame: Chemotherapy cycle 1,2,3 and 4 ]
    Blood, urine and saliva analysis

  4. Overall survival [ Time Frame: Over 4 years of the study ]
    Overall survival

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706627

Khon Kaen Hospital
Khon Kaen, Thailand, 40000
Srinagarind Hospital
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Srinagarind Hospital, Khon Kaen University
Khon Kaen Hospital, Khon Kaen
General Drug House Ltd., Bangkok
Thailand Research Fund
More Information

Responsible Party: Nutjaree Pratheepawanit Johns, Associate Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01706627     History of Changes
Other Study ID Numbers: MIRCIT
TRF ( Other Grant/Funding Number: Thailand Research Fund )
First Posted: October 15, 2012    Key Record Dates
Last Update Posted: October 15, 2012
Last Verified: October 2012

Keywords provided by Nutjaree Pratheepawanit Johns, Khon Kaen University:
adjuvant therapy
quality of life
adverse events
oxidative stress

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants