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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oil fish pearls | Experimental | patients with invasive breast cancer who received 640 mg oil fish pearls 3 times a day |
|
| placebo | Placebo Comparator | patient with invasive breast cancer who received corn oil pearls as placebo 3 times a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oil fish | Dietary Supplement | Active Comparator:640 mg oral oil fish pearls( 54% DHA, 10% EPA) 3 times a day |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zohreh Ghoreishi, Ph.D student | Contact | 0098 912 7390799 | zghoreishi@razi.tums.ac.ir | |
| seyed Ali Keshavarz, professor | Contact | 0098 912 1279306 | s_akeshavarz@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Seyed Ali Keshavarz, professor | Tehran University of Medical Sciences | Principal Investigator |
| Zohreh Ghoreishi, Ph.D student | Tehran University of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| : Tehran University of Medical Sciences, School of Public Health | Recruiting | Tehran | Tehran Province | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22894640 | Derived | Ghoreishi Z, Esfahani A, Djazayeri A, Djalali M, Golestan B, Ayromlou H, Hashemzade S, Asghari Jafarabadi M, Montazeri V, Keshavarz SA, Darabi M. Omega-3 fatty acids are protective against paclitaxel-induced peripheral neuropathy: a randomized double-blind placebo controlled trial. BMC Cancer. 2012 Aug 15;12:355. doi: 10.1186/1471-2407-12-355. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
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| corn oil pearls | Other | corn oil pearls 3 times a day |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |