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Brief Title: Melatonin as Adjuvant Therapy in Breast Cancer Patients
Official Title: Melatonin in Improving the Quality of Life of Breast Cancer Patients and Reduction of Postoperative Pain and Chemotherapy Induced Toxicity
Study ID: NCT01557478
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Srinagarind Hospital, Khon Kaen, , Thailand
Maharat Nakorn Ratchasima Hospital, Nakorn Ratchasima, , Thailand
Name: Nutjaree P Johns, PharmD,PhD
Affiliation: Khon Kaen University
Role: PRINCIPAL_INVESTIGATOR