Omega-3 Fatty Acids and Chemotherapy-induced Neuropathy and Inflammation in Breast Cancer
October 29, 2011 updated by: Zohreh Ghoreishi, Tehran University of Medical Sciences
The Effects of Omega-3 Fatty Acids on Chemotherapy-induced Neuropathy and Inflammation in Patients With Breast Cancer
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Anticipated)
52
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- Recruiting
- : Tehran University of Medical Sciences, School of Public Health
-
Contact:
- Zohreh Ghoreishi, Ph.D student
- Phone Number: 0098 912 7390799
- Email: zghoreishi@razi.tums.ac.ir
-
Contact:
- seyed Ali Keshavarz, professor
- Phone Number: 0098 912 1279306
- Email: s_akeshavarz@yahoo.com
-
Principal Investigator:
- seyed Ali Keshavarz, professor
-
Principal Investigator:
- Zohreh Ghoreishi, Ph.D student
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: oil fish pearls
patients with invasive breast cancer who received 640 mg oil fish pearls 3 times a day
|
Active Comparator:640 mg oral oil fish pearls( 54% DHA, 10% EPA) 3 times a day
|
|
PLACEBO_COMPARATOR: placebo
patient with invasive breast cancer who received corn oil pearls as placebo 3 times a day
|
corn oil pearls 3 times a day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
first day and after 3 months (before chemotherapy with taxanes and at the end of the therapy
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
first day and after 3 months( before chemotherapy with taxanes and at the end of the therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Seyed Ali Keshavarz, professor, Tehran University of Medical Sciences
- Study Director: Zohreh Ghoreishi, Ph.D student, Tehran University of Medical Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (ANTICIPATED)
November 1, 2011
Study Completion (ANTICIPATED)
February 1, 2012
Study Registration Dates
First Submitted
January 13, 2010
First Submitted That Met QC Criteria
January 13, 2010
First Posted (ESTIMATE)
January 14, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
November 1, 2011
Last Update Submitted That Met QC Criteria
October 29, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 88-04-27-9683
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.