Clinical trial NCT01706627: Melatonin In Reduction of Chemotherapy-Induced Toxicity (MIRCIT) Trial
Official title: Melatonin In Cancer Patients Receiving Chemotherapy: A Randomized, Double Blind, Placebo, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Advanced Stage Cancer
Keywords: cancer
melatonin
adjuvant therapy
quality of life
survival
adverse events
oxidative stress
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
Collaborators: name: Srinagarind Hospital, Khon Kaen University
name: Khon Kaen Hospital, Khon Kaen
name: General Drugs House Co.,LTD.
name: Thailand Research Fund
First posted: 2012-10-15
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Quality of Life (FACT)
timeFrame: Change from baseline in total scores at 6 months after treatment
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: Baseline and 1,2,3 and 6 months after treatment
measure: Oxidative stress status
timeFrame: Chemotherapy cycles 1,2,3,4
measure: Melatonin level
timeFrame: Chemotherapy cycle 1,2,3 and 4
measure: Overall survival
timeFrame: Over 4 years of the study
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Khon Kaen Hospital
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
Study officials:
References: