NCT00668707

Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 709 (actual)
• Sponsor: The Canadian College of Naturopathic Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	melatonin	20 mgs ingested nightly
DIETARY_SUPPLEMENT	placebo	similar to experimental in all ways except for lack of active ingredient

Timeline

• Start date: 2007-09-01
• Primary completion: 2017-03-09
• Completion: 2017-11-30
• First posted: 2008-04-29
• Last updated: 2021-08-03
• Results posted: 2021-08-03

Locations

8 sites across 1 country: Canada