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


Phase 4
30 Years
65 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

The EMG-NCV test,The serum level of IL-1,IL-6,TNF-alpha and hs-CRP

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Seyed Ali Keshavarz, professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tehran University of Medical Sciences

Authority:

Iran: Ministry of Health

Study ID:

88-04-27-9683

NCT ID:

NCT01049295

Start Date:

April 2010

Completion Date:

February 2012

Related Keywords:

  • Breast Cancer
  • taxanes
  • breast cancer
  • n3 fatty acids
  • inflammation
  • Breast Neoplasms
  • Inflammation

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