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

October 29, 2011 updated by: Zohreh Ghoreishi, Tehran University of Medical Sciences

The Effects of Omega-3 Fatty Acids on Chemotherapy-induced Neuropathy and Inflammation in Patients With Breast Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Recruiting
        • : Tehran University of Medical Sciences, School of Public Health
        • Contact:
        • Contact:
        • Principal Investigator:
          • seyed Ali Keshavarz, professor
        • Principal Investigator:
          • Zohreh Ghoreishi, Ph.D student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
first day and after 3 months (before chemotherapy with taxanes and at the end of the therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
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
first day and after 3 months( before chemotherapy with taxanes and at the end of the therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ANTICIPATED)

November 1, 2011

Study Completion (ANTICIPATED)

February 1, 2012

Study Registration Dates

First Submitted

January 13, 2010

First Submitted That Met QC Criteria

January 13, 2010

First Posted (ESTIMATE)

January 14, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2011

Last Update Submitted That Met QC Criteria

October 29, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 88-04-27-9683

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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