There is evidence to support the use of melatonin, a natural health product, as an additional treatment aid for cancer patients. This study is designed to see if the daily ingestion of 20 milligrams of melatonin for one year can lower the incidence of developing lung cancer recurrence and/or death. Only patients with a diagnosis of non small cell lung cancer who are eligible for surgical resection can participate in the trial. The study will also be assessing for changes in quality of life, pain, fatigue, anxiety, sleep, and depression amongst the participants.
The trial employs a two-armed parallel placebo controlled trial design whereby patients with a diagnosis of non small cell lung cancer are randomized to receive either 20 mg of melatonin nightly or an identically matched placebo. All patients will be followed for two years with primary outcomes assessed at a two year time point and secondary outcomes evaluated throughout the course of the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
709
20 mgs ingested nightly
similar to experimental in all ways except for lack of active ingredient
Kelowna General Hospital
Kelowna, British Columbia, Canada
Fraser Health
Surrey, British Columbia, Canada
QEII Health Sciences Centre/Capital Health
Halifax, Nova Scotia, Canada
St. Joseph's/ McMaster University
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Ottawa General Hospital
Ottawa, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Canada
Lung Cancer Recurrence or Mortality - 2 Years
Disease-Free survival (DFS) at 2 years post-surgery. DFS is measured by the number of participants in both arms who have experienced a recurrence OR mortality at 2 years.
Time frame: 2 years
Quality of Life
Participant-reported quality of life using the European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire C-30 (EORTC QLQ C-30) and Lung Cancer 13 (EORTC QLQ LC13) questionnaires. Scores represent a value from 0-100. Symptom and LC13 scale: 0 represents best health, 100 worst health. Global and functional scales: 100 represents best health, 0 represents worst health. Full scoring algorithms available here: https://www.eortc.org/app/uploads/sites/2/2018/02/SCmanual.pdf
Time frame: 2 years
Fatigue
Measured using the Multidimensional Fatigue Inventory 20 (MFI-20) questionnaire. Scores are on a scale of 0-100, where 100 is the best health and 0 is the worst health.
Time frame: 2 years
Sleep
Measured using the Medical Outcomes Study (MOS) Sleep Survey. Scales used were Sleep Adequacy and Sleep problems Index II. Scores are on a scale of 0-100. Sleep Adequacy: 100 represents best health; 0 represents worst health. Problems index: 0 represents best health; 100 represents worst health.
Time frame: 2 years
Pain Levels
Calculated using the Brief Pain Inventory. Each scale ranges from 0-10, where 0 is no pain and 10 is the worst possible pain.
Time frame: 3 months
Anxiety
Measured using the Beck Anxiety Inventory. Scored range from 0-63, where 0 is no anxiety and 63 is the worst possible anxiety.
Time frame: 2 years
Depression
Measured using the Beck Depression Inventory II. Scores range from 0-63, where 0 is no depression and 63 is the worst possible depression.
Time frame: 2 years
Adverse Events (Chemotherapy)
Number of participants who experienced an adverse event related to their adjuvant chemotherapy
Time frame: 2 years
Lung Cancer Recurrence or Mortality - 5 Years
Measured as disease-free survival (DFS) at 5 years. DFS was measured by the incidence of a recurrence OR mortality up to 5 years post-surgery.
Time frame: up to 5 years
Blood Tests to Examine the Effects of Melatonin on the Immune System (Raw Values)
NK cell cytotoxicity changes from baseline to 6 months
Time frame: 6 months
Adverse Events (Radiation)
Number of participants who experienced an adverse event related to their adjuvant radiation therapy
Time frame: 2 years
Blood Tests to Examine the Effects of Melatonin on the Immune System (Comparison Between Groups)
Differences in NK cell cytotoxicity between both arms
Time frame: 6 months
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