Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality
NCT ID: NCT00668707
Last Updated: 2021-08-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
709 participants
INTERVENTIONAL
2007-09-30
2017-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Melatonin
To receive 20 mg of melatonin nightly for 1 year post-surgery
melatonin
20 mgs ingested nightly
Placebo
To receive 20 mg placebo nightly for 1 year post-surgery
placebo
similar to experimental in all ways except for lack of active ingredient
Interventions
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melatonin
20 mgs ingested nightly
placebo
similar to experimental in all ways except for lack of active ingredient
Eligibility Criteria
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Inclusion Criteria
* Eligible for surgical resection
* Willingness to adhere to randomized treatment
* Availability for follow-up schedule of visits
Exclusion Criteria
18 Years
ALL
No
Sponsors
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The Ottawa Hospital
OTHER
Lotte & John Hecht Memorial Foundation
OTHER
Gateway for Cancer Research
OTHER
The Canadian College of Naturopathic Medicine
OTHER
Responsible Party
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Principal Investigators
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Dugald MR Seely, ND, MSc
Role: PRINCIPAL_INVESTIGATOR
The Canadian College of Naturopathic Medicine
Andrew JE Seely, MD
Role: PRINCIPAL_INVESTIGATOR
The Ottawa Hospital
Locations
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Kelowna General Hospital
Kelowna, British Columbia, Canada
Fraser Health
Surrey, British Columbia, Canada
QEII Health Sciences Centre/Capital Health
Halifax, Nova Scotia, Canada
St. Joseph's/ McMaster University
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Ottawa General Hospital
Ottawa, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, , Canada
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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The Canadian College of Naturopathic Medicine
Other Identifiers
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2007077-01H
Identifier Type: -
Identifier Source: org_study_id
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