Adjuvant Melatonin in the Prevention of Recurrence and Mortality Following Lung Cancer Resection:
A Randomized Placebo Controlled Clinical Trial
Introduction
Melatonin is a Natural Health Product that has demonstrated anticancer activity in the laboratory, in observational studies, and in randomized clinical trials. Specifically, melatonin is a promising candidate in the treatment and prevention of lung cancer. We previously conducted a systematic review and meta-analysis of all randomized controlled trials involving melatonin in the treatment of cancer. The meta-analysis combined relative risks of mortality at one year for nine separate clinical trials involving a number of solid tumour cancer trials. The pooled results were highly significant, with risk of mortality being reduced by 34% (RR: 0.66 (95% CI: 0.59, 0.73; P £ 0.0001), translating into a number needed to treat (NNT) of 4 (i.e. for every four people treated with melatonin, one extra person would be alive at one year as a result of being given this intervention). These findings have been published by a single group of investigators based in Europe, and no independent study has been conducted in
Study Design
We are therefore conducting a randomized, placebo-controlled, blinded trial among 336 subjects who have been diagnosed with NSCLC and are scheduled for surgical resection.
Hypotheses
· Adjuvant melatonin will reduce the incidence of lung cancer recurrence of NSCLC two years after surgical resection.
· Adjuvant melatonin will reduce disease specific 2-year mortality following lung cancer resection.
· Melatonin will lead to a reduction in chemotherapy related toxicities and have no impact on post- surgical complications or adverse effects due to radiation therapy.
· Melatonin will lead to improved QOL, less fatigue, improved sleep, and have no impact on depression or anxiety in patients following lung cancer resection.
Current Status
As of end of May 2011, 193 participants have been enrolled across 3 actively enrolling sites: The Ottawa Hospital, London Health Sciences Centre,
Funding
The study is funded by the Lotte and John Hecht Memorial Foundation, through the
For more information, please contact:
Co-Principal Investigator
Dr. Dugald Seely
Associate Director of Research
The
Co-Principal Investigator
Dr. Andrew Seely
Thoracic Surgery & Critical Care Medicine
Associate Scientist, Ottawa Hospital Research Institute
Associate Professor,
Research Director, Division of Thoracic Surgery
Research Coordinator
Anna Fazekas, MA
Research Program Manager
Division of Thoracic Surgery
The