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

NCT ID: NCT01706627

Last Updated: 2012-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2012-06-30

Brief Summary

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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

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Conditions

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Advanced Stage Cancer

Keywords

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cancer melatonin adjuvant therapy quality of life survival adverse events oxidative stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Matched placebo

Matched placebo (identical formulation and delivery, without active ingredient)

Group Type PLACEBO_COMPARATOR

Matched placebo

Intervention Type DRUG

Matched placebo (identical formulation and delivery, without active ingredient)

Drug: 10 mg Melatonin

10 mg melatonin gelatin capsule

Group Type ACTIVE_COMPARATOR

10 mg Melatonin

Intervention Type DRUG

Active Comparator: Drug: Melatonin 10 mg

Drug: 20 mg Melatonin

20 mg melatonin gelatin capsule

Group Type ACTIVE_COMPARATOR

20 mg Melatonin

Intervention Type DRUG

Active Comparator: Drug: Melatonin 20 mg

Interventions

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10 mg Melatonin

Active Comparator: Drug: Melatonin 10 mg

Intervention Type DRUG

20 mg Melatonin

Active Comparator: Drug: Melatonin 20 mg

Intervention Type DRUG

Matched placebo

Matched placebo (identical formulation and delivery, without active ingredient)

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Srinagarind Hospital, Khon Kaen University

OTHER

Sponsor Role collaborator

Khon Kaen Hospital, Khon Kaen

UNKNOWN

Sponsor Role collaborator

General Drugs House Co.,LTD.

OTHER

Sponsor Role collaborator

Thailand Research Fund

OTHER

Sponsor Role collaborator

Khon Kaen University

OTHER

Sponsor Role lead

Responsible Party

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Nutjaree Pratheepawanit Johns

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Khon Kaen Hospital

Khon Kaen, Changwat Khon Kaen, Thailand

Site Status

Srinagarind Hospital

Khon Kaen, Changwat Khon Kaen, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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TRF

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MIRCIT

Identifier Type: -

Identifier Source: org_study_id