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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00668707 |
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Date of registration:
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25/04/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality
AMPLCaRe |
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Scientific title:
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Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality: A Randomized Placebo Controlled Clinical Trial |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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711 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00668707 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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Contacts
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Name:
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Andrew JE Seely, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Ottawa Hospital |
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Name:
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Dugald MR Seely, ND, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Canadian College of Naturopathic Medicine |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Non Small Cell Lung Cancer
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Intervention(s)
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Dietary Supplement: placebo
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Dietary Supplement: melatonin
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Primary Outcome(s)
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Lung Cancer Recurrence or mortality
[Time Frame: 2 years]
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Secondary Outcome(s)
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blood tests to examine the effects of melatonin on the immune system
[Time Frame: baseline (before starting melatonin) and 6 months post-op]
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lung cancer recurrence or mortality
[Time Frame: up to 5 years]
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Fatigue
[Time Frame: 2 years]
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Pain
[Time Frame: 3 months]
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Quality of Life
[Time Frame: 2 years]
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Anxiety
[Time Frame: 2 years]
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Sleep
[Time Frame: 2 years]
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Adverse events
[Time Frame: 2 years]
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Depression
[Time Frame: 2 years]
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Secondary ID(s)
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2007077-01H
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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