This trial aims to evaluate the use of omega-3 fatty acid supplements to prevent side effects caused by aromatase inhibitors. Aromatase inhibitors can cause arthralgia (bone and joint pain). The main outcomes to be investigated are the change in pain score and the change in joint symptoms. This trial is taking place in Cleveland and Columbus Ohio in the United States.
The details
Omega-3 fatty acids are essential for good health. It can be found in foods such as fish, but can also be taken as a supplement. Omega-3s have been previously used to prevent heart disease, reduce inflammation and help prevent bone and joint pain. It is thought that omega-3 supplements may prevent arthralgia caused by aromatase inhibitors used to treat breast cancer.
This study will evaluate the efficiency of omega-3 by looking at changes in pain scores and joint symptoms.
Who are they looking for?
This study will recruit 200 women who have stage I, II or III breast cancer. Patients who have received aromatase inhibitor therapy, chemotherapy or radiation can take part. Patients who have received tamoxifen in the past can also take part.
Patients who have metastatic cancer of any type will not be eligible. Those who have rheumatoid arthritis or any other autoimmune disorder cannot take part. Women with any heart problems, active infection, or psychiatric illness will be excluded. Those who have known allergies to fish or fish oil will also be excluded. Participants must not be taking warfarin or other blood thinners.
How will it work
Patients will be randomly divided into two groups. One group will receive omega-3 fatty acid supplementation orally once a day for six months. The other group will receive a placebo (substance with no active effect) orally once daily for six months.
The change in pain score and joint symptoms will be measured at different times after the trial.
