Omega-3 Fatty Acids and Chemotherapy-induced Neuropathy and Inflammation in Breast Cancer
The Effects of Omega-3 Fatty Acids on Chemotherapy-induced Neuropathy and Inflammation in Patients With Breast Cancer
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 breast-cancer
Started Apr 2010
Shorter than P25 for phase_4 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2010
CompletedFirst Posted
Study publicly available on registry
January 14, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedNovember 1, 2011
April 1, 2011
1.6 years
January 13, 2010
October 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The EMG-NCV test,The serum level of IL-1,IL-6,TNF-alpha and hs-CRP
first day and after 3 months (before chemotherapy with taxanes and at the end of the therapy
Secondary Outcomes (1)
The serum level of DHA and EPA fatty acids
first day and after 3 months( before chemotherapy with taxanes and at the end of the therapy
Study Arms (2)
oil fish pearls
EXPERIMENTALpatients with invasive breast cancer who received 640 mg oil fish pearls 3 times a day
placebo
PLACEBO COMPARATORpatient with invasive breast cancer who received corn oil pearls as placebo 3 times a day
Interventions
Active Comparator:640 mg oral oil fish pearls( 54% DHA, 10% EPA) 3 times a day
Eligibility Criteria
You may qualify if:
- Suffering from invasive breast cancer,not receiving any form of supplementations and oil fish
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
: Tehran University of Medical Sciences, School of Public Health
Tehran, Tehran Province, Iran
Related Publications (1)
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.
PMID: 22894640DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seyed Ali Keshavarz, professor
Tehran University of Medical Sciences
- STUDY DIRECTOR
Zohreh Ghoreishi, Ph.D student
Tehran University of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master of Nutrition
Study Record Dates
First Submitted
January 13, 2010
First Posted
January 14, 2010
Study Start
April 1, 2010
Primary Completion
November 1, 2011
Study Completion
February 1, 2012
Last Updated
November 1, 2011
Record last verified: 2011-04