Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality

Phase 3

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Dietary Supplement: placebo; Dietary Supplement: melatonin

• Registration Number: NCT00668707
• Lead Sponsor: The Canadian College of Naturopathic Medicine

Brief Summary

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

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 Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-04-25
• Study First Submitted QC: 2008-04-28
• Study First Posted: 2008-04-29
• Primary Completion: 2017-03-09
• Study Completion: 2017-11-30
• Results First Submitted: 2021-03-08
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-12
• Last Update Submitted: 2021-07-12
• Results First Posted: 2021-08-03
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 709

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	To receive 20 mg placebo nightly for 1 year post-surgery
Melatonin	melatonin	To receive 20 mg of melatonin nightly for 1 year post-surgery

Primary Outcome Measures

Name	Time	Method
Lung Cancer Recurrence or Mortality - 2 Years	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Life	2 years	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
Anxiety	2 years	Measured using the Beck Anxiety Inventory. Scored range from 0-63, where 0 is no anxiety and 63 is the worst possible anxiety.
Depression	2 years	Measured using the Beck Depression Inventory II. Scores range from 0-63, where 0 is no depression and 63 is the worst possible depression.
Pain Levels	3 months	Calculated using the Brief Pain Inventory. Each scale ranges from 0-10, where 0 is no pain and 10 is the worst possible pain.
Adverse Events (Chemotherapy)	2 years	Number of participants who experienced an adverse event related to their adjuvant chemotherapy
Adverse Events (Radiation)	2 years	Number of participants who experienced an adverse event related to their adjuvant radiation therapy
Blood Tests to Examine the Effects of Melatonin on the Immune System (Comparison Between Groups)	6 months	Differences in NK cell cytotoxicity between both arms
Fatigue	2 years	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.
Sleep	2 years	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.
Blood Tests to Examine the Effects of Melatonin on the Immune System (Raw Values)	6 months	NK cell cytotoxicity changes from baseline to 6 months
Lung Cancer Recurrence or Mortality - 5 Years	up to 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.

Trial Locations

Locations (8)

Kelowna General Hospital; 🇨🇦 Kelowna, British Columbia, Canada

Fraser Health; 🇨🇦 Surrey, British Columbia, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

St. Joseph's/ McMaster University; 🇨🇦 Hamilton, Ontario, Canada

QEII Health Sciences Centre/Capital Health; 🇨🇦 Halifax, Nova Scotia, Canada

Ottawa General Hospital; 🇨🇦 Ottawa, Ontario, Canada

University Health Network; 🇨🇦 Toronto, Ontario, Canada

Institut universitaire de cardiologie et de pneumologie de Québec; 🇨🇦 Quebec, Canada