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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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20 April 2015 |
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Main ID: |
NCT02294149 |
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Date of registration:
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17/11/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Vit D3 and Omega 3 in Chemo Induced Neuropathy
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Scientific title:
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A Randomized Controlled Trial of Mammalian Omega 3 With Vitamin D3 in Patients at Risk of Chemotherapy Induced Peripheral Neuropathy. |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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600 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02294149 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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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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Nathaniel Bouganim, MD |
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Address:
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Telephone:
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514-934-1934 |
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Email:
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nathaniel.bouganim@mail.mcgill.ca |
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Affiliation:
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Name:
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Ralph Maroun, MD |
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Address:
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Telephone:
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5147080701 |
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Email:
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ralph-maroun@hotmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Will be receiving chemotherapy(Platinums and/or Taxanes) in the following 2 weeks.
- Histologically confirmed diagnosis of cancer
- ECOG 0 to 2
Exclusion Criteria:
- Prior chemotherapy treatment
- Pre-existing peripheral PN due to DM,HIV, alcohol abuse, thyroid dysfunction and
hereditary PN associated disorders.
- Taking any nutritional supplement( fish oil, vitamins and minerals) at least there
months before enrollment.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cancer
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Neuropathy
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Intervention(s)
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Drug: placebo
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Drug: mammalian Omega 3 Fatty acids
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Primary Outcome(s)
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percentage of participants with a 50% decreases in Total neuropathy score
[Time Frame: 3 months]
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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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