Recruiting
Phase 3

Vit D3 & Omega 3

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT02294149

Conditions

Cancer

Neuropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

mammalian Omega 3 Fatty acids

placebo

Study Details

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.

Conditions

Cancer

Neuropathy

Study ID

NCT02294149

Start date

Jan, 2015

Status verified date

Apr, 2015

Completion date

Nov, 2016

Anticipated

Primary completion date

Apr, 2015

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

placebo

Primary outcome measure

  • percentage of participants with a 50% decreases in Total neuropathy score [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Ralph Maroun, MD

5147080701ralph-maroun@hotmail.com

Nathaniel Bouganim, MD

514-934-1934nathaniel.bouganim@mail.mcgill.ca

Locations

McGill university health center, Royal Victoria hospital

Recruiting

Montreal, Quebec, Canada, h3a 1a1

Contacts

Nathaniel Bouganim, MD

514-934-1934nathaniel.bouganim@mail.mcgill.ca

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Apr 7, 2015

Last verified

Apr, 2015

Keywords

  • chemotherapy
  • Omega 3

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2015-04-07.