Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality: A Randomized Placebo Controlled Clinical Trial

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Dietary Supplement: melatonin
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of non small cell lung cancer Eligible for surgical resection Willingness to adhere to randomized treatment Availability for follow-up schedule of visits Exclusion Criteria: Taking exogenous melatonin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin<br>To receive 20 mg of melatonin nightly for 1 year post-surgery | Dietary Supplement: melatonin<br>* 20 mgs ingested nightly<br>|
| Placebo Comparator: Placebo<br>To receive 20 mg placebo nightly for 1 year post-surgery | Dietary Supplement: placebo<br>* similar to experimental in all ways except for lack of active ingredient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 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. | 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. | 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. | 2 years | 
| Adverse Events (Chemotherapy) | Number of participants who experienced an adverse event related to their adjuvant chemotherapy | 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. | 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 | 6 months | 
| Adverse Events (Radiation) | Number of participants who experienced an adverse event related to their adjuvant radiation therapy | 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melatonin, natural health product (NHP), lung cancer, complementary and alternative medicine (CAM), randomized clinical trial