- Aromatase inhibitor (AI) therapy is given to post-menopausal women to stop estrogen production and starve breast cancer cells.
- Postmenopausal women experience significant pain as a side effect of AI therapy.
- Depression drug duloxetine helps reduce pain in these women
Duloxetine drug used to treat depression and anxiety can help lower joint pain in postmenopausal women who are being treated for early-stage breast cancer.
Investigators from SWOG, the international cancer clinical trials network funded by the National Cancer Institute (NCI), conducted a randomized, placebo-controlled trial to test the effectiveness of duloxetine in alleviating joint pain.
‘Duloxetine which is primarily used to treat depression and anxiety helps relieve joint pain in postmenopausal women with early-stage breast cancer.’
The clinical trial called S1202 was led by Dr. N. Lynn Henry. A SWOG investigator from Huntsman Cancer Institute at the University of Utah and co-chair of SWOG's symptom control and quality of life committee.
Each year postmenopausal women are being treated with aromatase inhibitors (AIs), drugs to stop estrogen production and essentially starve hormone receptor-positive breast cancer cells. 50% of the women experience joint pain and stiffness as side effect of AI therapy. The pain associated with the AI therapy is so common and has a name: AI-Associated Musculoskeletal Syndrome (AIMSS).
Henry wanted to conduct a research to address the common problem faced by women with breast cancer.
"A lot of 60-year-old women report feeling like they're 80," Henry said. "The pain can really interfere with daily life. And this is a big problem. The length of treatment with AIs can be five to 10 years, so we're asking a lot of women to manage significant discomfort for a very long period of time."
The initial clinical trial results revealed that acupuncture and exercise were found to reduce symptoms of AIMSS but there is no evidence for an effective solution for all women.
So Henry wanted to study the effect of duloxetine on relieving AIMSS symptoms.
299 adult patients were enrolled to S1202 at 43 institutions throughout the NCI's National Cancer Trials Network (NCTN) and the NCI Community Oncology Research Program (NCORP). The patients were divided into two groups
Group I received duloxetine
Group II on placebo
The duration of medication dose was for 12 weeks.
During this period the participants were asked to fill out a questionnaire upon enrolling and again at two, six, 12 and 24 weeks into the study. The questionnaire focused on pain, rated on a 0-10 scale, and also on depression and quality of life.
Patients on duloxetine saw their average pain drop on the scale from 5.5 to about 3.
In these patients the improvement was rapid, and relief persisted through the end of the 12-week trial.
"We've shown that this treatment is a potential option for women," Dr. Henry said. "Taking this drug may help them tolerate their breast cancer treatment. And it's important for their health that they stick with their treatment."
The new SWOG research is presented at a special plenary presentation at the San Antonio Breast Cancer Symposium.
Duloxetine belongs to the class of selective serotonin and norepinephrine reuptake inhibitors. The drug works by increasing the levels of serotonin and norepinephrine. Serotonin and norepinephrine are the natural substances in the brain that help maintain mental balance and halt the movement of pain signals in the brain.
Duloxetine sold as Cymbalta is used to treat
- Depression and generalized anxiety disorder (GAD)
- Pain and tingling caused by diabetic neuropathy