NCT02294149

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for phase_3 cancer

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_3 cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

3 months

First QC Date

November 17, 2014

Last Update Submit

April 6, 2015

Conditions

CancerNeuropathy

Keywords

chemotherapyOmega 3

Outcome Measures

Primary Outcomes (1)

  • percentage of participants with a 50% decreases in Total neuropathy score

    3 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Omega 3 FA/Vitamin D3 sublingual

EXPERIMENTAL

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

Interventions

mammalian Omega 3 Fatty acidsDRUG

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.

Omega 3 FA/Vitamin D3 sublingual
placeboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Will be receiving chemotherapy(Platinums and/or Taxanes) in the following 2 weeks.
  • Histologically confirmed diagnosis of cancer
  • ECOG 0 to 2

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill university health center, Royal Victoria hospital

Montreal, Quebec, h3a 1a1, Canada

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Ralph Maroun, MD

CONTACT

5147080701ralph-maroun@hotmail.com

Nathaniel Bouganim, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Nathaniel Bouganim, Medical Oncologist at Royal Victoria Hospital muhc

Study Record Dates

First Submitted

November 17, 2014

First Posted

November 19, 2014

Study Start

January 1, 2015

Primary Completion

April 1, 2015

Study Completion

November 1, 2016

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

CA(1)