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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 4

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

oil fish

corn oil pearls

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring taxanes, breast cancer, n3 fatty acids, inflammation

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

: Tehran University of Medical Sciences, School of Public HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

oil fish pearls

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The serum level of DHA and EPA fatty acids

Full Information

NCT ID

NCT01049295

First Posted

January 13, 2010

Last Updated

October 29, 2011

Sponsor

Tehran University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01049295

Brief Title

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

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Unknown status

Study Start Date

April 2010 (undefined)

Primary Completion Date

November 2011 (Anticipated)

Study Completion Date

February 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

taxanes, breast cancer, n3 fatty acids, inflammation

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

oil fish pearls

Arm Type

Experimental

Arm Description

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

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

oil fish

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

corn oil pearls

Intervention Description

corn oil pearls 3 times a day

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zohreh Ghoreishi, Ph.D student

Phone

0098 912 7390799

zghoreishi@razi.tums.ac.ir

First Name & Middle Initial & Last Name or Official Title & Degree

seyed Ali Keshavarz, professor

Phone

0098 912 1279306

s_akeshavarz@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Seyed Ali Keshavarz, professor

Organizational Affiliation

Tehran University of Medical Sciences

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Zohreh Ghoreishi, Ph.D student

Organizational Affiliation

Tehran University of Medical Sciences

Official's Role

Study Director

Facility Information:

Facility Name

: Tehran University of Medical Sciences, School of Public Health

City

Tehran

Country

Iran, Islamic Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zohreh Ghoreishi, Ph.D student

Phone

0098 912 7390799

zghoreishi@razi.tums.ac.ir

First Name & Middle Initial & Last Name & Degree

seyed Ali Keshavarz, professor

Phone

0098 912 1279306

s_akeshavarz@yahoo.com

First Name & Middle Initial & Last Name & Degree

seyed Ali Keshavarz, professor

First Name & Middle Initial & Last Name & Degree

Zohreh Ghoreishi, Ph.D student

12. IPD Sharing Statement

Citations:

PubMed Identifier

22894640

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.

Results Reference

derived

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

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