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Melatonin as Adjuvant Therapy in Breast Cancer Patients (MIQOL-B)

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ClinicalTrials.gov Identifier: NCT01557478
Recruitment Status : Unknown
Verified January 2015 by Nutjaree Pratheepawanit Johns, Khon Kaen University.
Recruitment status was:  Active, not recruiting
First Posted : March 19, 2012
Last Update Posted : January 8, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stage II and III Breast Cancer Drug: Melatonin Drug: match placebo Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Melatonin in Improving the Quality of Life of Breast Cancer Patients and Reduction of Postoperative Pain and Chemotherapy Induced Toxicity
Study Start Date : March 2012
Estimated Primary Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Melatonin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Matched placebo
Matched placebo (identical formulation and delivery, without active ingredient)
Drug: match placebo
placebo gelatin capsule (1) taken orally after 21:00 hours each night throughout the study
Active Comparator: Melatonin 20mg
20 mg melatonin gelatin capsule
Drug: Melatonin
20 mg melatonin gelatin capsule (1) taken orally after 21:00 hours each night throughout the study

Outcome Measures

Primary Outcome Measures :
  1. Quality of Life (FACT-B Version 4) [ Time Frame: Change from baseline in TOI scores at 6 months ]
    Self-reported questionnaire. FACT-B Thai Version 4 has been previously validated. Change from baseline will be evaluated at months 2,4,6,12,18,24.

Secondary Outcome Measures :
  1. Pain and amount of pain medication used [ Time Frame: Before and up to 72 hours after surgery. ]
    Self-reported VAS scale (0-10)

  2. Number of participants with adverse events [ Time Frame: Baseline and months 2,3,4,5,6,12,18,24 ]
    CTCAE Version 4.3

  3. Sleep quality [ Time Frame: Baseline, up to 72 hours after surgery and months 2,3,4,5,6,12,18,24 ]
    Self reported VAS scale (0-10)

  4. Cancer recurrence incidence [ Time Frame: participant will be followed for the duration of study, an expected average of 2 years ]
  5. Progression-free survival [ Time Frame: participant will be followed for the duration of study, an expected average of 2 years ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557478

Srinagarind Hospital
Khon Kaen, Thailand, 40002
Maharat Nakorn Ratchasima Hospital
Nakorn Ratchasima, Thailand
Sponsors and Collaborators
Khon Kaen University
National Research Council of Thailand
Srinagarind Hospital, Khon Kaen University
Maharat Hospital, Nakhon Ratchasima
General Drug House Ltd., Bangkok
Principal Investigator: Nutjaree P Johns, PharmD,PhD Khon Kaen University
More Information

Responsible Party: Nutjaree Pratheepawanit Johns, Associate Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01557478     History of Changes
Other Study ID Numbers: MIQOL-B
First Posted: March 19, 2012    Key Record Dates
Last Update Posted: January 8, 2015
Last Verified: January 2015

Keywords provided by Nutjaree Pratheepawanit Johns, Khon Kaen University:
breast cancer
adjuvant therapy
quality of life
adverse events

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants