A Phase 4 interventional study of oil fish and corn oil pearls in Breast Cancer, sponsored by Tehran University of Medical Sciences. Status unknown at 1 site in Iran, Islamic Republic of. Open to female participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-11-01.
Sponsored by Tehran University of Medical Sciences · Phase 4, Interventional, and Supportive care
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).
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 52 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Tehran University of Medical Sciences is the lead sponsor of 227 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients with invasive breast cancer who received 640 mg oil fish pearls 3 times a day
Dietary Supplement: oil fish
patient with invasive breast cancer who received corn oil pearls as placebo 3 times a day
Other: corn oil pearls
Active Comparator:640 mg oral oil fish pearls( 54% DHA, 10% EPA) 3 times a day
corn oil pearls 3 times a day
The EMG-NCV test,The serum level of IL-1,IL-6,TNF-alpha and hs-CRP
Time frame: first day and after 3 months (before chemotherapy with taxanes and at the end of the therapy
The serum level of DHA and EPA fatty acids
Time frame: first day and after 3 months( before chemotherapy with taxanes and at the end of the therapy
This study is status unknown, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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Tehran University of Medical Sciences