Omega-3-Fatty Acid on Joint Symptoms Inducted by Aromatase Inhibitors
This study has been terminated.
(Closed by sponsor.)
Information provided by (Responsible Party):
Dawn L. Hershman, Columbia University
First received: June 29, 2009
Last updated: February 19, 2013
Last verified: February 2013
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.
Dietary Supplement: Omega-3 Fatty Acid
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
||Randomized Phase II Study of Omega-3-Fatty Acid on Joint Symptoms Induced by Aromatase Inhibitors in Breast Cancer Patients
Primary Outcome Measures:
- A change in serum free and total estradiol levels. [ Time Frame: At week 3 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- A change in the frequency of analgesics consumed [ Time Frame: At 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2011 (Final data collection date for primary outcome measure)
Dietary Supplement: Omega-3 Fatty Acid
4g per day for 3 weeks
Other Name: Lovaza
There are no data regarding the use of these supplements in other types of musculoskeletal pain and discomfort, namely AI induced joint pain and joint stiffness. Given the lack of effective treatments for AI induced joint pain/ stiffness and the safety and efficacy of omega 3 fatty acid for musculoskeletal pain, it is therefore reasonable to test the efficacy of these dietary supplements in a population of postmenopausal breast cancer patients who experience joint pain related to aromatase inhibitors. Since women with hormone receptor positive breast cancer require long term hormonal therapy, an important objective is minimizing long term side effects to enhance patient compliance and improve quality of life.
|Ages Eligible for Study:
||21 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930527
|Columbia University Medical Center
|New York, New York, United States, 10032 |
||Dawn Hershman, MD
No publications provided
||Dawn L. Hershman, Associate Professor of Medicine & Epidemiology, Columbia University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 29, 2009
||February 19, 2013
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 10, 2014
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action