Vit D3 and Omega 3 in Chemo Induced Neuropathy
Primary Purpose
Cancer, Neuropathy
Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
mammalian Omega 3 Fatty acids
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Cancer focused on measuring chemotherapy, Omega 3
Eligibility 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.
Sites / Locations
- McGill university health center, Royal Victoria hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Omega 3 FA/Vitamin D3 sublingual
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
percentage of participants with a 50% decreases in Total neuropathy score
Secondary Outcome Measures
Full Information
NCT ID
NCT02294149
First Posted
November 17, 2014
Last Updated
April 6, 2015
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
1. Study Identification
Unique Protocol Identification Number
NCT02294149
Brief Title
Vit D3 and Omega 3 in Chemo Induced Neuropathy
Official Title
A Randomized Controlled Trial of Mammalian Omega 3 With Vitamin D3 in Patients at Risk of Chemotherapy Induced Peripheral Neuropathy.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
November 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Neuropathy
Keywords
chemotherapy, Omega 3
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Omega 3 FA/Vitamin D3 sublingual
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
mammalian Omega 3 Fatty acids
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
percentage of participants with a 50% decreases in Total neuropathy score
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ralph Maroun, MD
Phone
5147080701
Email
ralph-maroun@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nathaniel Bouganim, MD
Phone
514-934-1934
Ext
34970
Email
nathaniel.bouganim@mail.mcgill.ca
Facility Information:
Facility Name
McGill university health center, Royal Victoria hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
h3a 1a1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathaniel Bouganim, MD
Phone
514-934-1934
Ext
34970
Email
nathaniel.bouganim@mail.mcgill.ca
12. IPD Sharing Statement
Learn more about this trial
Vit D3 and Omega 3 in Chemo Induced Neuropathy
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