Vit D3 and Omega 3 in Chemo Induced Neuropathy

Phase 3

• Conditions: Cancer; Neuropathy
• Interventions: Drug: placebo; Drug: mammalian Omega 3 Fatty acids

• Registration Number: NCT02294149
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Study Timeline

• Study First Submitted: 2014-11-17
• Study First Submitted QC: 2014-11-18
• Study First Posted: 2014-11-19
• Study Start: 2015-01
• Status Verified: 2015-04
• Primary Completion: 2015-04
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-07
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Omega 3 FA/Vitamin D3 sublingual	mammalian Omega 3 Fatty acids	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.

Primary Outcome Measures

Name	Time	Method
percentage of participants with a 50% decreases in Total neuropathy score	3 months

Trial Locations

Locations (1)

McGill university health center, Royal Victoria hospital; 🇨🇦 Montreal, Quebec, Canada