Vit D3 and Omega 3 in Chemo Induced Neuropathy

Cancer Clinical Trial

Official title:

A Randomized Controlled Trial of Mammalian Omega 3 With Vitamin D3 in Patients at Risk of Chemotherapy Induced Peripheral Neuropathy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02294149
• Other study ID #: 4086
• Status: Recruiting
• Phase: Phase 3
• First received: November 17, 2014
• Last updated: April 6, 2015
• Start date: January 2015
• Est. completion date: November 2016

Study information

• Verified date: April 2015
• Source: McGill University Health Center
• Contact: Ralph Maroun, MD
• Phone: 5147080701
• Email: ralph-maroun[@]hotmail.com
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: November 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer
• Neuropathy

Intervention

Drug:
• mammalian 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.
• placebo

Locations

Country	Name	City	State
Canada	McGill university health center, Royal Victoria hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of participants with a 50% decreases in Total neuropathy score		3 months	No