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

Phase 2

Completed

• Conditions: Advanced Stage Cancer
• Interventions: Drug: Matched placebo; Drug: 10 mg Melatonin; Drug: 20 mg Melatonin

• Registration Number: NCT01706627
• Lead Sponsor: Khon Kaen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2011-12
• Study Completion: 2012-06
• Status Verified: 2012-10
• Study First Submitted: 2012-10-11
• Study First Submitted QC: 2012-10-11
• Last Update Submitted: 2012-10-11
• Study First Posted: 2012-10-15
• Last Update Posted: 2012-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Matched placebo	Matched placebo	Matched placebo (identical formulation and delivery, without active ingredient)
Drug: 10 mg Melatonin	10 mg Melatonin	10 mg melatonin gelatin capsule
Drug: 20 mg Melatonin	20 mg Melatonin	20 mg melatonin gelatin capsule

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Srinagarind Hospital; 🇹🇭 Khon Kaen, Thailand

Khon Kaen Hospital; 🇹🇭 Khon Kaen, Thailand