Although the Helen F. Graham Cancer Center & Research Institute at Christiana Care has been the site of scores of clinical trials over the years, a recently completed study in breast cancer patients marks the first time that a clinical trial was designed, sponsored and run by Graham Cancer Center researchers.
For the study titled “Directed Exercise Intervention in Breast Cancer Patients with Arthralgias Receiving Aromatase Inhibitors: A Randomized Pilot Study,” Graham Cancer Center investigators compared a directed exercise regimen with walking in reducing joint pain, a common side effect of the class of estrogen-blocking drugs called aromatase inhibitors (AIs). These drugs are often a first-line therapy after surgery and radiation for women with estrogen receptor-positive breast cancer, the most common type of breast cancer.
The study results, in 27 women, showed that the directed exercise regimen — focused on joint mobility and stretching — may be superior to walking in reducing joint pain in women taking AIs.
Although AIs cause fewer side effects than older hormonal drugs, joint stiffness and pain are uncomfortable enough that 25 percent to 50 percent of patients who take AIs discontinue them or reduce the required dosage due to pain and stiffness. This means that many patients may be putting themselves at risk of facing a cancer recurrence.
Surgeon Diana Dickson-Witmer, M.D., medical director of the Christiana Care Breast Center and Breast Program at the Graham Cancer Center, pointed out how important AIs have been to breast cancer treatment, as they have enabled women to undergo less invasive and disfiguring procedures.
“Surgery for breast cancer, happily, has been becoming less and less aggressive for decades,” said Dr. Dickson-Witmer. “Our ability to continue to reduce the morbidity of surgery and radiotherapy for receptor-positive patients is predicated upon the assumption that they will be taking endocrine systemic therapy for five to 10 years. Exercise like that prescribed in this study can make a big difference in how much stiffness patients experience on endocrine therapy. That decrease in side effects of treatment can help thousands of women be compliant with the recommendation that they take an aromatase inhibitor every day for five to 10 years.”
Dr. Dickson-Witmer and the study’s principal investigator, oncologist Ramya Varadarajan, M.D., presented the study findings at the most recent San Antonio Breast Cancer Symposium in December. In April, the results were presented to the study volunteers during an event at the Graham Cancer Center, where the women were thanked for their participation in this milestone study for the center. The women in the control group, who did not do the directed exercises, were given a handout of the study exercises, with detailed instructions, at the event.
Pat DiIenno, 61, was one of those in the control group who received the exercises at the event and was excited to incorporate them into her routine. She said that being in the study was worthwhile and educational, even though she was not randomized to the intervention group.
“I felt good about participating in the study, because it’s important to do,” DiIenno said. “The most interesting part of the study for me was seeing all of the people involved at the Helen Graham Cancer Center.”
Before participating in the study, DiIenno said her relationship with the Cancer Center was largely with her physician only.
“There are many more people involved in our care than we realize,” she said.
Although she was in the control group, she said that simply participating in the study spurred her to move and exercise more. “I’m now doing a 30-minute workout, which is making a difference in my joint pain,” she said.
The directed exercise regimen, developed in collaboration with Christine Arnold, Ph.D., at Specialty Rehab, consisted of approximately 15 minutes of stretching and mobility exercises every day over an eight-week period. The exercises included hamstring stretches, quad stretches, calf muscle stretches, and various hand muscle strengthening and stretching exercises using putty.
Study investigator Jennifer Sims-Mourtada, Ph.D., director, Breast Cancer Translational Research, Center for Translational Cancer Research at the Graham Cancer Center, noted that Pfizer, the pharmaceutical company, which produces an AI (sold as Aromasin), will be distributing the intervention exercises to physicians worldwide as part of the company’s AI education program.
“This means that the results of this study will be distributed to women all over the world, and this hopefully will result in a benefit to their quality of life,” she said.
Sarah Erhart, 59, was a study participant who was randomized to the exercise intervention group. “I was glad to be able to participate to help others,” she said. “That’s a very rewarding feeling to help other people, help the doctors and help myself at the same time. You feel like a victim when you have cancer, and doing the exercises felt empowering. It feels like something you’re doing to fight back.”
Like DiIenno, Erhart said the study has spurred her to exercise more. She said she was extremely active before her cancer diagnosis in 2012 and is now back to cardio, weight training and swimming. She said the grip exercises were particularly helpful and that motivated her to seek out products she could use to work on grip strength, which she said was compromised by the feeling of arthritis in her hands. Simply opening jars and bottles was painful, she said, and required help from family members.
She liked the idea of using a drug-free approach to managing the arthritic side effects of the AIs, as she had tried arthritis medications and experienced uncomfortable side effects.
“My mother had cancer, too, and I do not want to go off of AIs no matter how bad the arthritis gets,” she said.
According to Dr. Varadarajan, one of the measurable ways that the directed exercise group showed improvement over the control group was significant improvement in grip strength and improvement in two-minute step tests and chair raises.
“This shows that patients are able to perform their activities of daily living better, and this will improve the compliance of taking their medication,” she said.