Depression Drug Reduces Joint Pain in Breast Cancer Patients

In a new randomized, placebo-controlled trial, investigators from SWOG (formerly the Southwest Oncology Group) have found that a depression and anxiety drug can go a long way toward reducing joint pain in postmenopausal women being treated for early stage breast cancer with aromatase inhibitors (which can sometimes cause joint pain). The SWOG researchers have determined that duloxetine (aka Cymbalta) can alleviate pain caused by these medications.

According to the December 9, 2016 news release, “N. Lynn Henry, M.D., Ph.D. led the clinical trial, called S1202. 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, Henry wanted to conduct the study because it addressed a common problem for women with breast cancer. Tens of thousands of postmenopausal women each year are treated with aromatase inhibitors (AIs), pills that stop the production of estrogen and essentially starve hormone receptor-positive breast cancer cells. Many women—as many as 50 percent— experience joint pain and stiffness as a side effect of AI therapy. About 20 percent experience significant pain. This can affect knees, hips, hands, and wrists, and make it difficult for women to walk, climb stairs, do simple tasks like type, or sit for an extended period of time.”

The pain has its own name: AI-Associated Musculoskeletal Syndrome (AIMSS).

“A lot of 60-year-old women report feeling like they’re 80, ” Dr. 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.”

“SWOG researchers enrolled 299 adult patients to S1202 at 43 institutions throughout the NCI’s [National Cancer Institute] National Cancer Trials Network (NCTN) and the NCI Community Oncology Research Program (NCORP). Those 299 patients were randomly assigned to either receive duloxetine or a placebo for 12 weeks. They filled out a questionnaire upon enrolling, and again at two, six, 12 and 24 weeks into the study. Questions focused on pain, rated on a 0-10 scale, and also on depression and quality of life.”

“Results showed that patients taking duloxetine saw their average pain drop on the scale from 5.5 to about 3. Improvement was rapid, and relief persisted through the end of the 12-week trial. Improvement in pain was also seen in the placebo arm of the trial, suggesting a robust placebo effect. Henry will present her findings at one of six plenary sessions at the San Antonio Breast Cancer Symposium, a leading cancer research conference with an international audience.”

“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.”

Dr. Henry told OTW, “Joint pain and stiffness occur in about half of women treated with aromatase inhibitor medications, which suppress estrogen production and are used routinely to reduce the risk of breast cancer recurrence. These bothersome symptoms can lead to discontinuation of treatment. We conducted this clinical trial of duloxetine versus placebo for treatment of aromatase inhibitor-associated arthralgias because of the significant discomfort that many women have while taking these medications to treat their breast cancer.”

“It is important for orthopedic surgeons to be aware of aromatase inhibitor-associated joint pain and stiffness, since it can worsen pain from pre-existing arthritis. Therefore, if a breast cancer patient taking an aromatase inhibitor has worsening joint pain, it may not be that her arthritis is worsening and requires surgical intervention. Rather, it may be due to the aromatase inhibitor medication, and a trial of duloxetine or a brief discontinuation of aromatase inhibitor therapy may be more appropriate for initial management.”

“Our next steps are to identify which patients are likely to have less pain while taking duloxetine, so that we can select patients likely to benefit from treatment and identify alternative treatments for those who don’t respond. In addition, one of the most interesting aspects of our study was the high placebo response rate, and we intend to investigate it further since it may yield other insights into treatment for this toxicity.”