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

Sponsor

Khon Kaen University (Other)

Overall Status

Completed

CT.gov ID

NCT01706627

Collaborator

Srinagarind Hospital, Khon Kaen University (Other), Khon Kaen Hospital, Khon Kaen (Other), General Drugs House Co.,LTD. (Other), Thailand Research Fund (Other)

175

Enrollment

Locations

Arms

Duration (Months)

87.5

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

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

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 :

Aug 1, 2007

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Jun 1, 2012

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

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

Quality of Life (FACT) [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

Number of participants with adverse events [Baseline and 1,2,3 and 6 months after treatment]
CTCAE Version 4.3
Oxidative stress status [Chemotherapy cycles 1,2,3,4]
8-isoprostane and 8-hydroxydeoxyguanosine urine and MDA plasma analysis
Melatonin level [Chemotherapy cycle 1,2,3 and 4]
Blood, urine and saliva analysis
Overall survival [Over 4 years of the study]
Overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).