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 Centre/Research Institute of the McGill University Health Centre.
Recruitment status was: Recruiting
First Posted : November 19, 2014
Last Update Posted : April 7, 2015
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Condition or disease | Intervention/treatment | Phase |
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Cancer Neuropathy | Drug: mammalian Omega 3 Fatty acids Drug: placebo | Phase 3 |
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 |
Arm | Intervention/treatment |
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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.
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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.
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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. |
- 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 |
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.

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
Contact: Ralph Maroun, MD | 5147080701 | ralph-maroun@hotmail.com | |
Contact: Nathaniel Bouganim, MD | 514-934-1934 ext 34970 | nathaniel.bouganim@mail.mcgill.ca |
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 |
Responsible Party: | Nathaniel Bouganim, Dr. Nathaniel Bouganim, Medical Oncologist at Royal Victoria Hospital muhc, McGill University Health Centre/Research Institute of the McGill University Health Centre |
ClinicalTrials.gov Identifier: | NCT02294149 |
Other Study ID Numbers: |
4086 |
First Posted: | November 19, 2014 Key Record Dates |
Last Update Posted: | April 7, 2015 |
Last Verified: | April 2015 |
chemotherapy Omega 3 |
Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases |