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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Tehran University of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Zohreh Ghoreishi, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01049295
First received: January 13, 2010
Last updated: October 29, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Dietary Supplement: oil fish
Other: corn oil pearls
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effects of Omega-3 Fatty Acids on Chemotherapy-induced Neuropathy and Inflammation in Patients With Breast Cancer

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: April 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oil fish pearls
patients with invasive breast cancer who received 640 mg oil fish pearls 3 times a day
Dietary Supplement: oil fish
Active Comparator:640 mg oral oil fish pearls( 54% DHA, 10% EPA) 3 times a day
Placebo Comparator: placebo
patient with invasive breast cancer who received corn oil pearls as placebo 3 times a day
Other: corn oil pearls
corn oil pearls 3 times a day

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).

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01049295

Contacts
Contact: Zohreh Ghoreishi, Ph.D student 0098 912 7390799 zghoreishi@razi.tums.ac.ir
Contact: seyed Ali Keshavarz, professor 0098 912 1279306 s_akeshavarz@yahoo.com

Locations
Iran, Islamic Republic of
: Tehran University of Medical Sciences, School of Public Health Recruiting
Tehran, Iran, Islamic Republic of
Contact: Zohreh Ghoreishi, Ph.D student    0098 912 7390799    zghoreishi@razi.tums.ac.ir   
Contact: seyed Ali Keshavarz, professor    0098 912 1279306    s_akeshavarz@yahoo.com   
Principal Investigator: seyed Ali Keshavarz, professor         
Principal Investigator: Zohreh Ghoreishi, Ph.D student         
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Principal Investigator: Seyed Ali Keshavarz, professor Tehran University of Medical Sciences
Study Director: Zohreh Ghoreishi, Ph.D student Tehran University of Medical Sciences
  More Information

No publications provided by Tehran University of Medical Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zohreh Ghoreishi, Master of Nutrition, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01049295     History of Changes
Other Study ID Numbers: 88-04-27-9683
Study First Received: January 13, 2010
Last Updated: October 29, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
taxanes
breast cancer
n3 fatty acids
inflammation

Additional relevant MeSH terms:
Breast Neoplasms
Inflammation
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014