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

This study has been completed.
Sponsor:
Collaborators:
Melatonin research Group Khon Kaen University
Srinagarind Hospital, Khon Kaen University
Khon Kaen Hospital, Khon Kaen
General Drug House Ltd., Bangkok
Thailand Research Fund
Information provided by (Responsible Party):
Nutjaree Pratheepawanit Johns, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT01706627
First received: October 11, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted

October 11, 2012
October 11, 2012
August 2007
December 2011   (final data collection date for primary outcome measure)
Quality of Life (FACT) [ Time Frame: Change from baseline in total scores at 6 months after treatment ] [ Designated as safety issue: No ]
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.
Same as current
No Changes Posted
  • Number of participants with adverse events [ Time Frame: Baseline and 1,2,3 and 6 months after treatment ] [ Designated as safety issue: No ]
    CTCAE Version 4.3
  • Oxidative stress status [ Time Frame: Chemotherapy cycles 1,2,3,4 ] [ Designated as safety issue: No ]
    8-isoprostane and 8-hydroxydeoxyguanosine urine and MDA plasma analysis
  • Melatonin level [ Time Frame: Chemotherapy cycle 1,2,3 and 4 ] [ Designated as safety issue: No ]
    Blood, urine and saliva analysis
  • Overall survival [ Time Frame: Over 4 years of the study ] [ Designated as safety issue: No ]
    Overall survival
Same as current
Not Provided
Not Provided
 
Melatonin In Reduction of Chemotherapy-Induced Toxicity (MIRCIT) Trial
Melatonin In Cancer Patients Receiving Chemotherapy: A Randomized, Double Blind, Placebo, Controlled 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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Advanced Stage Cancer
  • 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)
    Other Name: Matched placebo
  • Placebo Comparator: Matched placebo
    Matched placebo (identical formulation and delivery, without active ingredient)
    Intervention: Drug: Matched placebo
  • Active Comparator: Drug: 10 mg Melatonin
    10 mg melatonin gelatin capsule
    Intervention: Drug: 10 mg Melatonin
  • Active Comparator: Drug: 20 mg Melatonin
    20 mg melatonin gelatin capsule
    Intervention: Drug: 20 mg Melatonin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
175
June 2012
December 2011   (final data collection date for primary outcome measure)

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).
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01706627
MIRCIT, TRF
No
Nutjaree Pratheepawanit Johns, Khon Kaen University
Khon Kaen University
  • Melatonin research Group Khon Kaen University
  • Srinagarind Hospital, Khon Kaen University
  • Khon Kaen Hospital, Khon Kaen
  • General Drug House Ltd., Bangkok
  • Thailand Research Fund
Not Provided
Khon Kaen University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP