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

NCT ID: NCT01049295

Last Updated: 2011-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-02-29

Brief Summary

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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

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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).

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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oil fish pearls

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

Group Type EXPERIMENTAL

oil fish

Intervention Type DIETARY_SUPPLEMENT

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

placebo

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

Group Type PLACEBO_COMPARATOR

corn oil pearls

Intervention Type OTHER

corn oil pearls 3 times a day

Interventions

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oil fish

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

Intervention Type DIETARY_SUPPLEMENT

corn oil pearls

corn oil pearls 3 times a day

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Zohreh Ghoreishi

Master of Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seyed Ali Keshavarz, professor

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Zohreh Ghoreishi, Ph.D student

Role: STUDY_DIRECTOR

Tehran University of Medical Sciences

Locations

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: Tehran University of Medical Sciences, School of Public Health

Tehran, Tehran Province, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Zohreh Ghoreishi, Ph.D student

Role: CONTACT

[email protected]
0098 912 7390799

seyed Ali Keshavarz, professor

Role: CONTACT

[email protected]
0098 912 1279306

Facility Contacts

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Zohreh Ghoreishi, Ph.D student

Role: primary

[email protected]
0098 912 7390799

seyed Ali Keshavarz, professor

Role: backup

[email protected]
0098 912 1279306

References

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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.

Reference Type DERIVED
PMID: 22894640 (View on PubMed)

Other Identifiers

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88-04-27-9683

Identifier Type: -

Identifier Source: org_study_id