Clinical Trials Directory

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UnknownNCT01049295

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

The Effects of Omega-3 Fatty Acids on Chemotherapy-induced Neuropathy and Inflammation in Patients With Breast Cancer

Status
Unknown
Phase
Phase 4
Study type
Interventional
Enrollment
52 (estimated)
Sponsor
Tehran University of Medical Sciences · Academic / Other
Sex
Female
Age
30 Years – 65 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENToil fishActive Comparator:640 mg oral oil fish pearls( 54% DHA, 10% EPA) 3 times a day
OTHERcorn oil pearlscorn oil pearls 3 times a day

Timeline

Start date
2010-04-01
Primary completion
2011-11-01
Completion
2012-02-01
First posted
2010-01-14
Last updated
2011-11-01

Locations

1 site across 1 country: Iran

Source: ClinicalTrials.gov record NCT01049295. Inclusion in this directory is not an endorsement.