Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-30 @ 2:43 PM
Study NCT ID:
NCT01049295
Status:
UNKNOWN
Last Update Posted:
2011-11-01
First Post:
2010-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omega-3 Fatty Acids and Chemotherapy-induced Neuropathy and Inflammation in Breast Cancer
Sponsor:
Tehran University of Medical Sciences
Organization:
Study Overview
Official Title:
The Effects of Omega-3 Fatty Acids on Chemotherapy-induced Neuropathy and Inflammation in Patients With Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2011-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: