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

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ClinicalTrials.gov Identifier: NCT01049295
Recruitment Status : Unknown
Verified April 2011 by Zohreh Ghoreishi, Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : January 14, 2010
Last Update Posted : November 1, 2011
Sponsor:
Information provided by (Responsible Party):
Zohreh Ghoreishi, Tehran University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE January 13, 2010
First Posted Date  ICMJE January 14, 2010
Last Update Posted Date November 1, 2011
Study Start Date  ICMJE April 2010
Estimated Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01049295 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2010)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Omega-3 Fatty Acids and Chemotherapy-induced Neuropathy and Inflammation in Breast Cancer
Official Title  ICMJE The Effects of Omega-3 Fatty Acids on Chemotherapy-induced Neuropathy and Inflammation in Patients With Breast Cancer
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Dietary Supplement: oil fish
    Active Comparator:640 mg oral oil fish pearls( 54% DHA, 10% EPA) 3 times a day
  • Other: corn oil pearls
    corn oil pearls 3 times a day
Study Arms  ICMJE
  • Experimental: oil fish pearls
    patients with invasive breast cancer who received 640 mg oil fish pearls 3 times a day
    Intervention: Dietary Supplement: oil fish
  • Placebo Comparator: placebo
    patient with invasive breast cancer who received corn oil pearls as placebo 3 times a day
    Intervention: Other: corn oil pearls
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 13, 2010)
52
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2012
Estimated Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01049295
Other Study ID Numbers  ICMJE 88-04-27-9683
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zohreh Ghoreishi, Tehran University of Medical Sciences
Study Sponsor  ICMJE Tehran University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Seyed Ali Keshavarz, professor Tehran University of Medical Sciences
Study Director: Zohreh Ghoreishi, Ph.D student Tehran University of Medical Sciences
PRS Account Tehran University of Medical Sciences
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP