Melatonin as Adjuvant Therapy in Breast Cancer Patients
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Khon Kaen University
Collaborators:
General Drug House Ltd., Bangkok General Drugs House Co.,LTD. Maharat Hospital, Nakhon Ratchasima National Research Council of Thailand Srinagarind Hospital, Khon Kaen University