Vit D3 and Omega 3 in Chemo Induced Neuropathy

Last updated: April 6, 2015
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Overall Status: Trial Status Unknown

Phase

3

Condition

Cancer

Neuropathy

Treatment

N/A

Clinical Study ID

NCT02294149
4086
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Prior chemotherapy treatment

  • Pre-existing peripheral PN due to DM,HIV, alcohol abuse, thyroid dysfunction andhereditary PN associated disorders.

  • Taking any nutritional supplement( fish oil, vitamins and minerals) at least theremonths before enrollment.

Study Design

Total Participants: 600
Study Start date:
January 01, 2015
Estimated Completion Date:
November 30, 2016

Study 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.

Connect with a study center

  • McGill university health center, Royal Victoria hospital

    Montreal, Quebec h3a 1a1
    Canada

    Active - Recruiting

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