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
  Purpose

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 Intervention Phase
Advanced Stage Cancer
Drug: 10 mg Melatonin
Drug: 20 mg Melatonin
Drug: Matched placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Melatonin In Cancer Patients Receiving Chemotherapy: A Randomized, Double Blind, Placebo, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 175
Study Start Date: August 2007
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Other Name: Matched placebo
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706627

Locations
Thailand
Srinagarind Hospital
Khon Kaen, Thailand, 40002
Khon Kaen Hospital
Khon Kaen, Thailand, 40000
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Nutjaree Pratheepawanit Johns, Associate Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01706627     History of Changes
Other Study ID Numbers: MIRCIT, TRF
Study First Received: October 11, 2012
Last Updated: October 11, 2012
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen University:
cancer
melatonin
adjuvant therapy
quality of life
survival
adverse events
oxidative stress

Additional relevant MeSH terms:
Melatonin
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on July 23, 2014