Trial | NCT01557478  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    melatonin ...

  • Study Participants

    166
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.
Study Started
Mar 31
2012
Primary Completion
Sep 30
2016
Anticipated
Last Update
Jan 08
2015
Estimate

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

Matched placebo Placebo Comparator

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

Melatonin 20mg Active Comparator

20 mg melatonin gelatin capsule

Criteria 

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).
No Results Posted