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

Tehran University of Medical Sciences

Status and phase: Unknown; Phase 4

Conditions: Breast Cancer

Treatments: Dietary Supplement: oil fish; Other: corn oil pearls

Study type: Interventional

Funder types: Other

Identifiers

NCT01049295

88-04-27-9683

Details and patient eligibility

About

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.

Full 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).

Enrollment: 52 estimated patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups, including a placebo group

oil fish pearls

Experimental group

Description:

patients with invasive breast cancer who received 640 mg oil fish pearls 3 times a day

Treatment:

Dietary Supplement: oil fish

placebo

Placebo Comparator group

Description:

patient with invasive breast cancer who received corn oil pearls as placebo 3 times a day

Treatment:

Other: corn oil pearls