Omega-3 Supplementation in Prevention of Aromatase Inhibitor-Induced Toxicity in Patients With Stage I-III Breast Cancer
NCT ID: NCT02831582
Last Updated: 2023-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
75 participants
INTERVENTIONAL
2016-10-12
2021-12-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Altering Lipids for Tolerance of Aromatase Inhibitor Therapy
NCT04268134
Dietary and Exercise Interventions in Reducing Side Effects in Patients With Stage I-IIIa Breast Cancer Receiving Aromatase Inhibitors
NCT03953157
5-strain Probiotic Formulation in HR-positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss
NCT07044310
Acupuncture in Treating Women With Stage I, Stage II, or Stage III Breast Cancer With Aromatase Inhibitor-Related Joint Pain
NCT01013337
Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention
NCT00723398
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To determine the efficacy of the complementary therapy omega-3 fatty acid (n-3 PUFA) supplementation in preventing aromatase inhibitor-induced arthralgias (AIIAs).
SECONDARY OBJECTIVES:
I. To prospectively define the population most at risk for developing AIIAs by the identification and validation of genetic risk predictors and to develop a single nucleotide polymorphism (SNP)/gene profile predictive of treatment intervention response.
OUTLINE: Patients are randomized to 1 of 2 groups.
Group I: Patients receive omega-3 fatty acid supplementation orally (PO) once daily (QD) for 6 months.
Group II: Patients receive placebo PO QD for 6 months.
After completion of study, patients will be followed up periodically.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm I (omega-3 fatty acid)
Patients receive omega-3 fatty acid supplementation PO QD for 6 months.
Omega-3 Fatty Acid
Given PO.
Arm II (placebo)
Patients receive placebo PO QD for 6 months.
Placebo
Given PO.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Omega-3 Fatty Acid
Given PO.
Placebo
Given PO.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Concurrent gonadotropin-releasing hormone (GnRH) agonist therapy is allowed; concurrent breast related radiation therapy is allowed.
* Prior tamoxifen use is allowed
* Prior chemotherapy is allowed
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
* Rheumatoid arthritis and other types of autoimmune and inflammatory joint disease
* AI use \> 21 days prior to study enrollment
* Known bleeding disorders
* Current use of warfarin or other anticoagulants
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
* Daily use of n-3 PUFA concentrates or capsules or any other supplements that might interact with n-3 PUFA supplements if \> 375 mg per day of of eicosapentaenoic acid (EPA)/ docosahexaenoic acid (DHA) within six months of study initiation
* Pregnant or nursing women
* Known sensitivity or allergy to fish or fish oil
* Unable to give informed consent
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nicole Williams
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nicole Williams, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
City of Hope
Duarte, California, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Roberts KE, Adsett IT, Rickett K, Conroy SM, Chatfield MD, Woodward NE. Systemic therapies for preventing or treating aromatase inhibitor-induced musculoskeletal symptoms in early breast cancer. Cochrane Database Syst Rev. 2022 Jan 10;1(1):CD013167. doi: 10.1002/14651858.CD013167.pub2.
Related Links
Access external resources that provide additional context or updates about the study.
The Jamesline
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2016-00377
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-15222
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.