Cancer, Neuropathy
Conditions
Keywords
chemotherapy, Omega 3
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.
Interventions
DRUGmammalian 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.
DRUGplacebo
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage of participants with a 50% decreases in Total neuropathy score | 3 months |
Countries
Canada
Contacts
Primary ContactRalph Maroun, MD
Backup ContactNathaniel Bouganim, MD
Outcome results
None listed