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Melatonin as Adjuvant Therapy in Breast Cancer Patients

NCT01557478 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2015-01-08

No results posted yet for this study

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.

Conditions

  • Stage II and III Breast Cancer

Interventions

DRUG

Melatonin

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

DRUG

match placebo

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

Sponsors & Collaborators

  • National Research Council of Thailand

    collaborator OTHER_GOV

  • Srinagarind Hospital, Khon Kaen University

    collaborator OTHER

  • Maharat Hospital, Nakhon Ratchasima

    collaborator UNKNOWN

  • General Drugs House Co.,LTD.

    collaborator OTHER

  • Khon Kaen University

    lead OTHER

Principal Investigators

  • Nutjaree P Johns, PharmD,PhD · Khon Kaen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2016-09-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01557478 on ClinicalTrials.gov