Melatonin as Adjuvant Therapy in Breast Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Melatonin in Improving the Quality of Life of Breast Cancer Patients and Reduction of Postoperative Pain and Chemotherapy Induced Toxicity

Conditions
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Stage II and III Breast Cancer

Intervention / Treatment
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* Drug: Melatonin
* Drug: match placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Matched placebo<br>Matched placebo (identical formulation and delivery, without active ingredient) | Drug: match placebo<br>* placebo gelatin capsule (1) taken orally after 21:00 hours each night throughout the study<br>|
| Active Comparator: Melatonin 20mg<br>20 mg melatonin gelatin capsule | Drug: Melatonin<br>* 20 mg melatonin gelatin capsule (1) taken orally after 21:00 hours each night throughout the study<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, melatonin, adjuvant therapy, quality of life, pain, sleep, survival, adverse events