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NCT Number: NCT01706627

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

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.

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Key information

Conditions

Advanced Stage Cancer Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Khon Kaen Hospital, Khon Kaen, Changwat Khon Kaen, Thailand

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

10 mg Melatonin

Drug

Active Comparator: Drug: Melatonin 10 mg

20 mg Melatonin

Drug

Active Comparator: Drug: Melatonin 20 mg

Matched placebo

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Collaborators

  • General Drugs House Co.,LTD.
  • Khon Kaen Hospital
  • Srinagarind Hospital, Khon Kaen University
  • Thailand Research Fund

Registry information

Official study title

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

Acronym: MIRCIT

Important dates

Study start
2007
Primary completion
2011
Study completion
2012
First posted
Oct 15, 2012
Registry last updated
Oct 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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