Omega-3-Fatty Acid on Joint Symptoms Inducted by Aromatase Inhibitors

NCT00930527 | Terminated Phase 2 DMC

• 1 other identifier: AAAD8300
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

There are no data regarding the use of supplements to alleviate the musculoskeletal pain and stiffness inducted by the use of aromatase inhibitors. This study is designated to test the safety and efficacy of omega 3 fatty acid supplementation to alleviate musculoskeletal pain in postmenopausal breast cancer patients.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• A change in serum free and total estradiol levels.

  At week 3

Secondary Outcomes (1)

• A change in the frequency of analgesics consumed

  At 12 weeks

Interventions

Omega-3 Fatty Acid DIETARY_SUPPLEMENT

4g per day for 3 weeks

Also known as: Lovaza

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>21 years
• Postmenopausal status defined as cessation of menses for \>1 year or FSH \>20 mIU/mL or bilateral oophorectomy.
• History of stage I, II or III hormone receptor-positive breast cancer, without metastatic disease
• Currently taking a third-generation aromatase inhibitor for at least 3 months
• Clinical symptoms of knee and/or hand joint pain and/or stiffness for at least 3 months prior to study entry
• Ongoing musculoskeletal pain/stiffness in hand and/or knee joints (50 or higher on the 100 point global assessment VAS) that started or increased since initiating aromatase inhibitor therapy, and has been present for at least 3 months.
• Patients must agree to refrain from use of omega-3-fatty acid from sources outside of this study
• If taking bisphosphonates, on a stable dose for at least 1 month and tolerating the dose. Patients must agree to refrain from initiating bisphosphonate use during the course of the study, therefore it is recommended that routine bone density testing be performed prior to enrollment or after completing trial.
• ECOG performance status 0-2.
• Signed informed consent

You may not qualify if:

• Use of omega-3-fatty acid within the past three (3) months
• Concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy including: Inflammatory arthritis (e.g., rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica), gout, episodes of acute monarticular arthritis clinically consistent with pseudogout, Paget's disease affecting the study joint, a history of septic arthritis or avascular necrosis or intra-articular fracture of the study joint, Wilson's disease, hemochromatosis, alkaptonuria, or primary osteochondromatosis.
• History of bone fracture or surgery of the afflicted knees and/or hands within 6 months prior to study entry.
• History of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient.
• Allergy to, or history of significant clinical or laboratory adverse experience associated with omega-3 fatty acid
• Inability to understand and complete study questionnaires including questions requiring a visual analog scale (VAS) response.
• Inability to understand the study procedures and/or give written informed consent.
• Alcohol use in excess of 3 mixed drinks/day.
• Corticosteroid treatment as follows:
• Use of oral corticosteroids within the previous four weeks.
• Exposure to intramuscular corticosteroids within one month prior to entering the study.
• Administration of intra-articular steroids to the study joint, within 3 months of Randomization Visit.
• Administration of intra-articular steroids to any other joint, within 3 months of Randomization Visit.
• Intra-articular injection of hyaluronic acid or congeners into the study joint within 12 months.
• Topical analgesics (e.g., capsaicin preparations) to the study joint, or any oral analgesics (e.g., opiates, tramadol; with the exception of ibuprofen and acetaminophen) within 2 weeks of Randomization Visit or during the study.

Sponsors & Collaborators

• Columbia University: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fatty Acids, Omega-3; Omacor

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Dawn Hershman, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine & Epidemiology

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: June 30, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 23, 2014

Record last verified: 2013-02

Locations

US (1)