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

March 13, 2012
June 11, 2012
March 2012
September 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01557478 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Melatonin as Adjuvant Therapy in Breast Cancer Patients
Melatonin in Improving the Quality of Life of Breast Cancer Patients and Reduction of Postoperative Pain and Chemotherapy Induced Toxicity

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Stage II and III Breast Cancer
  • Drug: Melatonin
    20 mg melatonin gelatin capsule (1) taken orally after 21:00 hours each night throughout the study
  • Drug: match placebo
    placebo gelatin capsule (1) taken orally after 21:00 hours each night throughout the study
  • Placebo Comparator: Matched placebo
    Matched placebo (identical formulation and delivery, without active ingredient)
    Intervention: Drug: match placebo
  • Active Comparator: Melatonin 20mg
    20 mg melatonin gelatin capsule
    Intervention: Drug: Melatonin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
Not Provided
September 2015   (final data collection date for primary outcome measure)

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).
Female
18 Years to 70 Years
No
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
Thailand
 
NCT01557478
MIQOL-B
No
Nutjaree Pratheepawanit Johns, Khon Kaen University
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
Principal Investigator: Nutjaree P Johns, PharmD,PhD Khon Kaen University
Khon Kaen University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP