NCT01557478

Melatonin as Adjuvant Therapy in Breast Cancer Patients

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Khon Kaen University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2012-03-01
• Primary completion: 2016-09-01
• First posted: 2012-03-19
• Last updated: 2015-01-08

Locations

2 sites across 1 country: Thailand