Melatonin as Adjuvant Therapy in Breast Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

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.

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Detailed Description

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Conditions

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Stage II and III Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Matched placebo

Matched placebo (identical formulation and delivery, without active ingredient)

Group Type PLACEBO_COMPARATOR

match placebo

Intervention Type DRUG

placebo gelatin capsule (1) taken orally after 21:00 hours each night throughout the study

Melatonin 20mg

20 mg melatonin gelatin capsule

Group Type ACTIVE_COMPARATOR

Melatonin

Intervention Type DRUG

20 mg melatonin gelatin capsule (1) taken orally after 21:00 hours each night throughout the study

Interventions

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Melatonin

20 mg melatonin gelatin capsule (1) taken orally after 21:00 hours each night throughout the study

Intervention Type DRUG

match placebo

placebo gelatin capsule (1) taken orally after 21:00 hours each night throughout the study

Intervention Type DRUG

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No