Melatonin as Adjuvant Therapy in Breast Cancer Patients

Khon Kaen University166 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

166

Conditions

Stage II and III Breast Cancer

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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).

Locations (2)

Srinagarind Hospital

Khon Kaen, Changwat Khon Kaen, Thailand

Maharat Nakorn Ratchasima Hospital

Nakorn Ratchasima, Nakorn Ratchasima, Thailand

Outcomes

Primary Outcomes

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.

Time frame: Change from baseline in TOI scores at 6 months

Secondary Outcomes

Pain and amount of pain medication used

Self-reported VAS scale (0-10)

Time frame: Before and up to 72 hours after surgery.

Number of participants with adverse events

CTCAE Version 4.3

Time frame: Baseline and months 2,3,4,5,6,12,18,24

Sleep quality

Self reported VAS scale (0-10)

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