Melatonin as Adjuvant Therapy in Breast Cancer Patients

Phase 2

• Conditions: Stage II and III Breast Cancer
• Interventions: Drug: match placebo; Drug: Melatonin

• Registration Number: NCT01557478
• Lead Sponsor: Khon Kaen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-13
• Study First Submitted QC: 2012-03-16
• Study First Posted: 2012-03-19
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-06
• Last Update Posted: 2015-01-08
• Primary Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 166

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Matched placebo	match placebo	Matched placebo (identical formulation and delivery, without active ingredient)
Melatonin 20mg	Melatonin	20 mg melatonin gelatin capsule

Primary Outcome Measures

Name	Time	Method
Quality of Life (FACT-B Version 4)	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

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

Trial Locations

Locations (2)

Maharat Nakorn Ratchasima Hospital; 🇹🇭 Nakorn Ratchasima, Thailand

Srinagarind Hospital; 🇹🇭 Khon Kaen, Thailand