Clinical trial NCT00668707: Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality
Official title: Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality: A Randomized Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non Small Cell Lung Cancer
Keywords: melatonin
natural health product (NHP)
lung cancer
complementary and alternative medicine (CAM)
randomized clinical trial
Lead sponsor: The Canadian College of Naturopathic Medicine
Sponsor class: OTHER
Collaborators: name: The Ottawa Hospital
name: Lotte & John Hecht Memorial Foundation
name: Gateway for Cancer Research
First posted: 2008-04-29
Enrollment: 709
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lung Cancer Recurrence or Mortality - 2 Years
timeFrame: 2 years
Secondary outcomes:
measure: Quality of Life
timeFrame: 2 years
measure: Fatigue
timeFrame: 2 years
measure: Sleep
timeFrame: 2 years
measure: Pain Levels
timeFrame: 3 months
measure: Anxiety
timeFrame: 2 years
measure: Depression
timeFrame: 2 years
measure: Adverse Events (Chemotherapy)
timeFrame: 2 years
measure: Lung Cancer Recurrence or Mortality - 5 Years
timeFrame: up to 5 years
measure: Blood Tests to Examine the Effects of Melatonin on the Immune System (Raw Values)
timeFrame: 6 months
measure: Adverse Events (Radiation)
timeFrame: 2 years
measure: Blood Tests to Examine the Effects of Melatonin on the Immune System (Comparison Between Groups)
timeFrame: 6 months
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: Kelowna General Hospital
state: British Columbia
city: Surrey
country: Canada
facility: Fraser Health
state: British Columbia
city: Halifax
country: Canada
facility: QEII Health Sciences Centre/Capital Health
state: Nova Scotia
city: Hamilton
country: Canada
facility: St. Joseph's/ McMaster University
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa General Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Quebec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec
Study officials:
affiliation: The Canadian College of Naturopathic Medicine
name: Dugald MR Seely, ND, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: The Ottawa Hospital
name: Andrew JE Seely, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mills E, Wu P, Seely D, Guyatt G. Melatonin in the treatment of cancer: a systematic review of randomized controlled trials and meta-analysis. J Pineal Res. 2005 Nov;39(4):360-6. doi: 10.1111/j.1600-079X.2005.00258.x.
citation: Seely D, Wu P, Fritz H, Kennedy DA, Tsui T, Seely AJ, Mills E. Melatonin as adjuvant cancer care with and without chemotherapy: a systematic review and meta-analysis of randomized trials. Integr Cancer Ther. 2012 Dec;11(4):293-303. doi: 10.1177/1534735411425484. Epub 2011 Oct 21.
citation: Seely D, Legacy M, Auer RC, Fazekas A, Delic E, Anstee C, Angka L, Kennedy MA, Tai LH, Zhang T, Maziak DE, Shamji FM, Sundaresan RS, Gilbert S, Villeneuve PJ, Ashrafi AS, Inculet R, Yasufuku K, Waddell TK, Finley C, Shargall Y, Plourde M, Fergusson DA, Ramsay T, Seely AJE. Adjuvant melatonin for the prevention of recurrence and mortality following lung cancer resection (AMPLCaRe): A randomized placebo controlled clinical trial. EClinicalMedicine. 2021 Feb 27;33:100763. doi: 10.1016/j.eclinm.2021.100763. eCollection 2021 Mar.