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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01049295
Enrollment
52
Registered
2010-01-14
Start date
2010-04-30
Completion date
2012-02-29
Last updated
2011-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

taxanes, breast cancer, n3 fatty acids, inflammation

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).

Interventions

DIETARY_SUPPLEMENToil fish

Active Comparator:640 mg oral oil fish pearls( 54% DHA, 10% EPA) 3 times a day

OTHERcorn oil pearls

corn oil pearls 3 times a day

Sponsors

Tehran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The EMG-NCV test,The serum level of IL-1,IL-6,TNF-alpha and hs-CRPfirst day and after 3 months (before chemotherapy with taxanes and at the end of the therapy

Secondary

MeasureTime frame
The serum level of DHA and EPA fatty acidsfirst day and after 3 months( before chemotherapy with taxanes and at the end of the therapy

Countries

Iran

Contacts

Primary ContactZohreh Ghoreishi, Ph.D student
zghoreishi@razi.tums.ac.ir0098 912 7390799
Backup Contactseyed Ali Keshavarz, professor
s_akeshavarz@yahoo.com0098 912 1279306

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026