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

Advanced Stage Cancer Clinical Trial

— MIRCIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01706627
• Other study ID #: MIRCIT
• Secondary ID: TRF
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 11, 2012
• Last updated: October 11, 2012
• Start date: August 2007
• Est. completion date: June 2012

Study information

• Verified date: October 2012
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Stage Cancer

Intervention

Drug:
• 10 mg Melatonin
Active Comparator: Drug: Melatonin 10 mg
• 20 mg Melatonin
Active Comparator: Drug: Melatonin 20 mg
• Matched placebo
Matched placebo (identical formulation and delivery, without active ingredient)

Locations

Country	Name	City	State
Thailand	Khon Kaen Hospital	Khon Kaen
Thailand	Srinagarind Hospital	Khon Kaen

Sponsors (5)

Lead Sponsor	Collaborator
Khon Kaen University	General Drug House Ltd., Bangkok, Khon Kaen Hospital, Khon Kaen, Srinagarind Hospital, Khon Kaen University, Thailand Research Fund

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life (FACT)	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.	Change from baseline in total scores at 6 months after treatment	No
Secondary	Number of participants with adverse events	CTCAE Version 4.3	Baseline and 1,2,3 and 6 months after treatment	No
Secondary	Oxidative stress status	8-isoprostane and 8-hydroxydeoxyguanosine urine and MDA plasma analysis	Chemotherapy cycles 1,2,3,4	No
Secondary	Melatonin level	Blood, urine and saliva analysis	Chemotherapy cycle 1,2,3 and 4	No
Secondary	Overall survival	Overall survival	Over 4 years of the study	No