An earlier clinical trial provided the pilot data needed to secure a $2.9 million grant, awarded by the National Center for Complementary and Alternative Medicine for the five-year project. The randomized, controlled, multi-site study of women with breast cancer will begin enrollment this month, said principal investigator Joseph Roscoe, Ph.D., research associate professor at the James P. Wilmot Cancer Center at URMC.
Despite being such a widespread problem, nausea is a difficult condition to investigate. Although physicians prescribe the best available anti-nausea medication during cancer treatment, not all drugs work equally well on each person. In addition, past experiences (such as pregnancy-induced nausea or susceptibility to motion sickness) and other cultural factors and information, can have an effect on the patient’s experience.
Evidence shows that some complementary and alternative therapies might help control nausea. Relaxation or guided imagery techniques, for example, have been found to reduce anxiety, which has an indirect connection to feeling nauseous, Roscoe said. For years people also have used wrist bands, a form of Chinese acupuncture, to ease nausea by stimulating a point on the wrist that restores energy flow.
In this study, however, researchers are not only investigating the alternative therapies – but the best ways to provide written and spoken information to patients about alternative medicine.
All 216 patients will receive standard anti-nausea drugs, but two-thirds of the women will be randomly assigned by a computer to also wear acupressure wrist bands following chemotherapy and listen to a relaxing, 12-minute, MP3 musical recording. Not everyone will get the same information about the wristbands and the recordings, though. An important aspect of the study is to discover what type of information imparted to patients is most effective. One third of the study volunteers will serve as the control group and won’t receive any relaxation therapies or additional information.
Patients will keep daily diaries about nausea for five days during their first and second chemotherapy treatments. To qualify for the study, women must be scheduled to receive one of four common chemotherapy regimens for breast cancer. The MP3 will feature a soothing voice offering suggestions for feeling better. Patients can use the relaxation techniques as much or as little as they desire.
By studying the best way to communicate with patients, Roscoe said, researchers hope to generate data that could apply more broadly, beyond cancer, to our understanding of how the mind impacts physical symptoms.
“We’re really trying to find out how to offer information in such a way that we can actually reduce symptoms and side effects,” Roscoe said. “And with an emphasis on patient-centered care, it’s apparent that communication becomes even more important as people try to understand every part of the treatment process.”
Roscoe is part of Wilmot’s Cancer Control Program, which has been continuously funded since 1975 to investigate ways to improve the quality of life of people who have cancer, or who were treated for it. Wilmot is partnering with three other cancer clinics to enroll study volunteers: Roswell Park Cancer Institute in Buffalo, Lipson Cancer Center at Rochester General Health System, and Hematology/Oncology Associates of Central New York in Syracuse.
For more than a decade the Cancer Control Program has been looking at nausea and why it occurs in some people more than others. Of all breast cancer patients who receive chemotherapy, about half experience some degree of nausea, Roscoe said. Most often it’s mild, but a significant number of people do get moderate to severe, debilitating nausea – and this latter group is the focus of his research.
Cancer Control also investigates chemo-induced cognition problems, insomnia and fatigue related to cancer treatment, and exercise interventions for cancer patients.
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