Lung Cancer Clinical Trial; Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality (AMPLCaRe)

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Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality (AMPLCaRe)
This study is currently recruiting participants.
Verified by The Canadian College of Naturopathic Medicine, January 2009
Sponsors and Collaborators: The Canadian College of Naturopathic Medicine
Ottawa General Hospital

Information provided by: The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier: NCT00668707

Purpose
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.



Condition Intervention Phase
Non Small Cell Lung Cancer
Dietary Supplement: melatonin
Dietary Supplement: placebo
Phase III




MedlinePlus related topics: Anxiety Cancer Depression Lung Cancer
Drug Information available for: Melatonin
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality: A Randomized Placebo Controlled Clinical Trial


Further study details as provided by The Canadian College of Naturopathic Medicine:


Primary Outcome Measures:
Lung Cancer Recurrence [ Time Frame: 2 years ] [ Designated as safety issue: No ]



Secondary Outcome Measures:
Quality of Life [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Fatigue [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Sleep [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Anxiety [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Depression [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]


Estimated Enrollment: 330
Study Start Date: September 2007
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
To receive 20 mg of melatonin nightly for 1 year Dietary Supplement: melatonin
20 mgs ingested nightly
2: Placebo Comparator
To receive matched supplement to the experimental arm in same schedule Dietary Supplement: placebo
similar to experimental in all ways except for lack of active ingredient


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


Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

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
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668707


Contacts
Contact: Andrew JE Seely, MD 613-737-8899 ext 74892 aseely@ottawahospital.on.ca
Contact: Dugald MR Seely, ND 416-498-1255 ext 387 dseely@ccnm.edu


Locations
Canada, Ontario
Ottawa General Hospital Recruiting
Ottawa, Ontario, Canada, K1Y 1J7
Principal Investigator: Andrew JE Seely, MD
Sub-Investigator: Donna Maziak, MD
Sub-Investigator: Farid Shamji, MD
Sub-Investigator: Sudhir Sundaresan, MD
Sub-Investigator: Scott Laurie, MD
Sub-Investigator: Rob McRae, MD

Sponsors and Collaborators
The Canadian College of Naturopathic Medicine
Ottawa General Hospital
Investigators
Principal Investigator: Dugald MR Seely, ND, MSc The Canadian College of Naturopathic Medicine
Principal Investigator: Andrew JE Seely, MD Ottawa General Hospital

More Information


The Canadian College of Naturopathic Medicine

Publications:
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. Review.

Responsible Party: Canadian College of Naturopathic Medicine ( Dugald Seely )
Study ID Numbers: 2007077-01H
Study First Received: April 25, 2008
Last Updated: January 27, 2009
ClinicalTrials.gov Identifier: NCT00668707 [history]
Health Authority: Canada: Health Canada

Keywords provided by The Canadian College of Naturopathic Medicine:
melatonin
natural health product (NHP)
lung cancer
complementary and alternative medicine (CAM)
randomized clinical trial



Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Melatonin
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma



Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Antioxidants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Protective Agents
Central Nervous System Agents
Pharmacologic Actions



ClinicalTrials.gov processed this record on February 10, 2009


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