Omega-3 Fatty Acids and Chemotherapy-induced Neuropathy and Inflammation in Breast Cancer

Phase 4

• Conditions: Breast Cancer
• Interventions: Dietary Supplement: oil fish; Other: corn oil pearls

• Registration Number: NCT01049295
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

The aim of this study is to assess the effects of n-3 fatty acids on taxane-induced neuropathy and neurotoxic inflammatory agents in patients suffering from invasive breast cancer.

Detailed Description

Breast cancer is the most common malignancy in women. Chemotherapy with taxanes in patients with breast cancer causes some complications and neuropathy is one of the most frequent that is dose limiting and even may cause to stop the therapy. n-3 fatty acids have very significant role in improvement the function of the neurons.n-3 fatty acids decrease the demyelination and toxicities resulting from taxanes. They also lower the level of of the neurotoxic inflammatory agents. So,n-3 fatty acids improve the quality of life in this patients. 52 patients with invasive breast cancer will be randomized in a double-blind placebo-controlled manner to receive either 640 mg oil fish pearls( 54% DHA, 10% EPA) 3 times a day or placebo( corn oil pearls) for 3 months(during the chemotherapy with taxanes). Neuropathy (using EMG-NCV test)and the level of IL-1,IL-6, TNF-alpha, hs-crp and serum level of EPA and DHA fatty acids will be measured before chemotherapy with taxanes and at the end of the therapy (after 3 months).

Study Timeline

• Study First Submitted: 2010-01-13
• Study First Submitted QC: 2010-01-13
• Study First Posted: 2010-01-14
• Study Start: 2010-04
• Status Verified: 2011-04
• Last Update Submitted: 2011-10-29
• Primary Completion: 2011-11
• Last Update Posted: 2011-11-01
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 52

Inclusion Criteria

• Suffering from invasive breast cancer,not receiving any form of supplementations and oil fish

Exclusion Criteria

• Suffering from the diseases leading to neuropathy, e.g.diabetes, hyperthyroidism, AIDS and primary neural diseases
• Suffering from any other kind of malignancies
• Receiving any chemotherapeutical agents in the past

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oil fish pearls	oil fish	patients with invasive breast cancer who received 640 mg oil fish pearls 3 times a day
placebo	corn oil pearls	patient with invasive breast cancer who received corn oil pearls as placebo 3 times a day

Primary Outcome Measures

Name	Time	Method
The EMG-NCV test,The serum level of IL-1,IL-6,TNF-alpha and hs-CRP	first day and after 3 months (before chemotherapy with taxanes and at the end of the therapy

Secondary Outcome Measures

Name	Time	Method
The serum level of DHA and EPA fatty acids	first day and after 3 months( before chemotherapy with taxanes and at the end of the therapy

Trial Locations

Locations (1)

: Tehran University of Medical Sciences, School of Public Health; 🇮🇷 Tehran, Iran, Islamic Republic of