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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Dietary Supplement: oil fish
* Other: corn oil pearls


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oil fish pearls<br>patients with invasive breast cancer who received 640 mg oil fish pearls 3 times a day | Dietary Supplement: oil fish<br>* Active Comparator:640 mg oral oil fish pearls( 54% DHA, 10% EPA) 3 times a day<br>|
| Placebo Comparator: placebo<br>patient with invasive breast cancer who received corn oil pearls as placebo 3 times a day | Other: corn oil pearls<br>* corn oil pearls 3 times a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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taxanes, breast cancer, n3 fatty acids, inflammation