Vit D3 and Omega 3 in Chemo Induced Neuropathy

McGill University

Status and phase: Unknown; Phase 3

Conditions: Cancer; Neuropathy

Treatments: Drug: placebo; Drug: mammalian Omega 3 Fatty acids

Study type: Interventional

Funder types: Other

Identifiers

NCT02294149

4086

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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600 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

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.

Treatment:

Drug: placebo

Omega 3 FA/Vitamin D3 sublingual

Experimental group

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.

Treatment:

Drug: mammalian Omega 3 Fatty acids