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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Khon Kaen University
Sponsor:
Collaborators:
National Research Council of Thailand
Melatonin research Group Khon Kaen University
Srinagarind Hospital, Khon Kaen University
Maharat Hospital, Nakhon Ratchasima
General Drug House Ltd., Bangkok
Information provided by (Responsible Party):
Nutjaree Pratheepawanit Johns, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT01557478
First received: March 13, 2012
Last updated: June 11, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Stage II and III Breast Cancer
Drug: Melatonin
Drug: match placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • Quality of Life (FACT-B Version 4) [ Time Frame: Change from baseline in TOI scores at 6 months ] [ Designated as safety issue: No ]
    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:
  • Pain and amount of pain medication used [ Time Frame: Before and up to 72 hours after surgery. ] [ Designated as safety issue: No ]
    Self-reported VAS scale (0-10)

  • Number of participants with adverse events [ Time Frame: Baseline and months 2,3,4,5,6,12,18,24 ] [ Designated as safety issue: No ]
    CTCAE Version 4.3

  • Sleep quality [ Time Frame: Baseline, up to 72 hours after surgery and months 2,3,4,5,6,12,18,24 ] [ Designated as safety issue: No ]
    Self reported VAS scale (0-10)

  • Cancer recurrence incidence [ Time Frame: participant will be followed for the duration of study, an expected average of 2 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: participant will be followed for the duration of study, an expected average of 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: March 2012
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557478

Contacts
Contact: Nutjaree P Johns, PharmD,PhD 6643202378 ext 1207 pnutja@kku.ac.th
Contact: Jeffrey R Johns, PhD 6643202378 ext 1524 jjeff@kku.ac.th

Locations
Thailand
Srinagarind Hospital Recruiting
Khon Kaen, Thailand, 40002
Sub-Investigator: Damnern Vachirodorm, MD         
Maharat Nakorn Ratchasima Hospital Recruiting
Nakorn Ratchasima, Thailand
Sub-Investigator: Sailuk Pimkow, MD         
Sponsors and Collaborators
Khon Kaen University
National Research Council of Thailand
Melatonin research Group Khon Kaen University
Srinagarind Hospital, Khon Kaen University
Maharat Hospital, Nakhon Ratchasima
General Drug House Ltd., Bangkok
Investigators
Principal Investigator: Nutjaree P Johns, PharmD,PhD Khon Kaen University
  More Information

No publications provided

Responsible Party: Nutjaree Pratheepawanit Johns, Associate Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01557478     History of Changes
Other Study ID Numbers: MIQOL-B
Study First Received: March 13, 2012
Last Updated: June 11, 2012
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen University:
breast cancer
melatonin
adjuvant therapy
quality of life
pain
sleep
survival
adverse events

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

ClinicalTrials.gov processed this record on November 20, 2014