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

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.

Study Overview

• Status: Unknown
• Conditions: Stage II and III Breast Cancer
• Intervention / Treatment: Drug: match placebo; Drug: Melatonin

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Khon Kaen, Thailand, 40002
    • Srinagarind Hospital
  • Nakorn Ratchasima, Thailand
    • Maharat Nakorn Ratchasima Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life (FACT-B Version 4)	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.	Change from baseline in TOI scores at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain and amount of pain medication used	Self-reported VAS scale (0-10)	Before and up to 72 hours after surgery.
Number of participants with adverse events	CTCAE Version 4.3	Baseline and months 2,3,4,5,6,12,18,24
Sleep quality	Self reported VAS scale (0-10)	Baseline, up to 72 hours after surgery and months 2,3,4,5,6,12,18,24
Cancer recurrence incidence		participant will be followed for the duration of study, an expected average of 2 years
Progression-free survival		participant will be followed for the duration of study, an expected average of 2 years

Collaborators and Investigators

• Sponsor: Khon Kaen University
• Collaborators: National Research Council of Thailand; Srinagarind Hospital, Khon Kaen University; General Drugs House Co.,LTD.; Maharat Hospital, Nakhon Ratchasima
• Investigators: Principal Investigator: Nutjaree P Johns, PharmD,PhD, Khon Kaen University

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ANTICIPATED): September 1, 2016

Study Registration Dates

• First Submitted: March 13, 2012
• First Submitted That Met QC Criteria: March 16, 2012
• First Posted (ESTIMATE): March 19, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 8, 2015
• Last Update Submitted That Met QC Criteria: January 6, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: breast cancer; adjuvant therapy; pain; sleep; melatonin; quality of life; survival; adverse events
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: MIQOL-B