Clinical trial NCT01049295: Omega-3 Fatty Acids and Chemotherapy-induced Neuropathy and Inflammation in Breast Cancer
Official title: The Effects of Omega-3 Fatty Acids on Chemotherapy-induced Neuropathy and Inflammation in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Breast Cancer
Keywords: taxanes
breast cancer
n3 fatty acids
inflammation
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-01-14
Enrollment: 52
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: The EMG-NCV test,The serum level of IL-1,IL-6,TNF-alpha and hs-CRP
timeFrame: first day and after 3 months (before chemotherapy with taxanes and at the end of the therapy
Secondary outcomes:
measure: The serum level of DHA and EPA fatty acids
timeFrame: first day and after 3 months( before chemotherapy with taxanes and at the end of the therapy
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: : Tehran University of Medical Sciences, School of Public Health
Study officials:
affiliation: Tehran University of Medical Sciences
name: Seyed Ali Keshavarz, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran University of Medical Sciences
name: Zohreh Ghoreishi, Ph.D student
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1186/1471-2407-12-355.