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Vit D3 and Omega 3 in Chemo Induced Neuropathy

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ClinicalTrials.gov Identifier: NCT02294149
Recruitment Status : Unknown
Verified April 2015 by Nathaniel Bouganim, McGill University Health Center.
Recruitment status was:  Recruiting
First Posted : November 19, 2014
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
Nathaniel Bouganim, McGill University Health Center

Brief Summary:
The purpose of this study is to determine whether administration of mammalian Omega 3 FA(fatty acid) with Vitamin D3 supplements would lower or prevent the risk of neuropathy due to chemotherapy.

Condition or disease Intervention/treatment Phase
Cancer Neuropathy Drug: mammalian Omega 3 Fatty acids Drug: placebo Phase 3

Detailed Description:
The primary objective of this study is to evaluate the impact of mammalian oil Omega 3 FA with Vitamin D3 supplementation on resolution or prevention of Taxanes or Platinum induced peripheral neuropathy compared with placebo. Patients will be allocated to receive the Omega 3 FA & Vitamin D3 supplements or placebo for 6 months. Approximately 600 patients in total will be enrolled in the 2 study arms. The evaluation of neuropathy will be accomplished by electromyography (EMG), Total neuropathy score(TNS), Brief pain inventory (BFI) and the 11-item FACT/GOG-Ntx, version 4 questionnaire (a subscale validated to assess neuropathy due to chemotherapy). In addition, other validated functional measures such as "Time to button a six hole shirt" and "50 ft walk speed test" will be used to test patients physical limitations imposed by peripheral neuropathy. All our patients will undergo an EMG at their first visit, in 3 months and after 6months. Previously mentioned functional measures will also be completed at the patients' first visit, in 3 months and after 6 months.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Mammalian Omega 3 With Vitamin D3 in Patients at Risk of Chemotherapy Induced Peripheral Neuropathy.
Study Start Date : January 2015
Actual Primary Completion Date : April 2015
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Placebo Comparator: Placebo
A ineffective placebo drug with the same taste, route of administration and physical appearance as the study drug (omega 3/Vit D 3) that has received approval by health Canada.
Drug: placebo
Experimental: Omega 3 FA/Vitamin D3 sublingual
patients will be allocated randomly to receive Sub-lingual Omega 3 FA and Vitamin D3 supplements for 6 months, twice daily ,1/2 tea spoon with instructions to keep it under the tongue for 45 sec.
Drug: mammalian Omega 3 Fatty acids
A mammalian oil derived Omega 3 FA that is a further concentrated and purified supplement as compared to the regular fish oil derived Omega 3 FA supplement.




Primary Outcome Measures :
  1. percentage of participants with a 50% decreases in Total neuropathy score [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02294149


Contacts
Contact: Ralph Maroun, MD 5147080701 ralph-maroun@hotmail.com
Contact: Nathaniel Bouganim, MD 514-934-1934 ext 34970 nathaniel.bouganim@mail.mcgill.ca

Locations
Canada, Quebec
McGill university health center, Royal Victoria hospital Recruiting
Montreal, Quebec, Canada, h3a 1a1
Contact: Nathaniel Bouganim, MD    514-934-1934 ext 34970    nathaniel.bouganim@mail.mcgill.ca   
Sponsors and Collaborators
McGill University Health Center

Responsible Party: Nathaniel Bouganim, Dr. Nathaniel Bouganim, Medical Oncologist at Royal Victoria Hospital muhc, McGill University Health Center
ClinicalTrials.gov Identifier: NCT02294149     History of Changes
Other Study ID Numbers: 4086
First Posted: November 19, 2014    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015

Keywords provided by Nathaniel Bouganim, McGill University Health Center:
chemotherapy
Omega 3

Additional relevant MeSH terms:
Vitamins
Vitamin D
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents