This trial is active, not recruiting.

Condition stage ii and iii breast cancer
Treatments melatonin, match placebo
Phase phase 2/phase 3
Sponsor Khon Kaen University
Collaborator National Research Council of Thailand
Start date March 2012
End date September 2016
Trial size 166 participants
Trial identifier NCT01557478, MIQOL-B


The study evaluate the effect of melatonin in improving quality of life and reducing post operative pain and chemotherapy-induced toxicity in breast cancer patients. This is a multi-center, randomized, double-blind, placebo controlled trial conducted in stage II or III breast cancer patients. Mixed-block randomization, stratified by center and treatment scheme is used to divide eligible patients into two groups: melatonin 20 mg or matched placebo. The patients are required to take the studied drugs at night (after 21.00 pm) on the first night prior to surgery and continue for 24 months. Standard treatment is surgery followed by chemotherapy according to each center's standard protocol. Study endpoints are QOL (FACT-B), pain (VAS 0-10), adverse event frequency, sleep quality (VAS 0-10), recurrence rate and progression-free survival.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Placebo Comparator)
Matched placebo (identical formulation and delivery, without active ingredient)
match placebo
placebo gelatin capsule (1) taken orally after 21:00 hours each night throughout the study
(Active Comparator)
20 mg melatonin gelatin capsule
20 mg melatonin gelatin capsule (1) taken orally after 21:00 hours each night throughout the study

Primary Outcomes

Quality of Life (FACT-B Version 4)
time frame: Change from baseline in TOI scores at 6 months

Secondary Outcomes

Pain and amount of pain medication used
time frame: Before and up to 72 hours after surgery.
Number of participants with adverse events
time frame: Baseline and months 2,3,4,5,6,12,18,24
Sleep quality
time frame: Baseline, up to 72 hours after surgery and months 2,3,4,5,6,12,18,24
Cancer recurrence incidence
time frame: participant will be followed for the duration of study, an expected average of 2 years
Progression-free survival
time frame: participant will be followed for the duration of study, an expected average of 2 years

Eligibility Criteria

Female participants from 18 years up to 70 years old.

Inclusion Criteria: - histologically proven stage II or III breast 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) - New York Heart Association grade ≤ 2 - written consent Exclusion Criteria: - received prior chemotherapy or biotherapy, radiotherapy or surgery within 1 month preceding randomization, - had more than one type of cancer or brain metastasis - moderate neuropathy (CTCAE grade ≥ 2) - active infection - 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).

Additional Information

Official title Melatonin in Improving the Quality of Life of Breast Cancer Patients and Reduction of Postoperative Pain and Chemotherapy Induced Toxicity
Principal investigator Nutjaree P Johns, PharmD,PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Khon Kaen University.