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

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2010

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.

Intervention(s) in this Clinical Trial

• Dietary Supplement: melatonin
  • 20 mgs ingested nightly
• Dietary Supplement: placebo
  • similar to experimental in all ways except for lack of active ingredient

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • To receive 20 mg of melatonin nightly for 1 year
• Placebo Comparator: 2
  • To receive matched supplement to the experimental arm in same schedule

Primary Measures

• Lung Cancer Recurrence
  • Time Frame: 2 years
    Safety Issue?: No

Secondary Measures

• Quality of Life
  • Time Frame: 2 years
    Safety Issue?: No
• Fatigue
  • Time Frame: 2 years
    Safety Issue?: No
• Sleep
  • Time Frame: 2 years
    Safety Issue?: No
• Pain
  • Time Frame: 3 months
    Safety Issue?: No
• Anxiety
  • Time Frame: 2 years
    Safety Issue?: No
• Depression
  • Time Frame: 2 years
    Safety Issue?: No
• Adverse events
  • Time Frame: 2 years
    Safety Issue?: Yes
• Mortality
  • Time Frame: 2 years
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: The Canadian College of Naturopathic Medicine

Overall Clinical Trial Officials and Contacts

Dugald MR Seely, ND, MSc Principal Investigator The Canadian College of Naturopathic Medicine  

Overall Contact: Andrew JE Seely, MD 613-737-8899 aseely@ottawahospital.on.ca

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00668707

Study ID Number: 2007077-01H

ClinicalTrials.gov Identifier: NCT00668707

Health Authority: Canada: Health Canada

The Canadian College of Naturopathic Medicine