The focus of the clinical research is YOCAS©®, a type of yoga therapy developed at the University of Rochester Medical Center to be used for cancer-related side effects. It integrates gentle hatha yoga and restorative yoga postures with strong meditation and relaxation techniques. The flow of each session was designed to assist the body in maintaining a normal 24-hour circadian rhythm cycle and healthy sleep patterns.
Led by Karen M. Mustian, Ph.D., MPH, an expert in exercise oncology and physiology, investigators will directly compare YOCAS©® to cognitive behavioral therapy for insomnia (CBT-I). In addition, they will analyze the influence of YOCAS©® on heart, lung and muscle function, blood biomarkers of inflammation, and circadian rhythms.
“We believe YOCAS©® will be just as good, or better than the current gold-standard treatment for insomnia, which is CBT-I,” said Mustian, an associate professor of Surgery, Cancer, and Radiation Oncology, and a scientist in Wilmot’s Cancer Control and Survivorship program. “We will also be examining whether YOCAS©® can positively influence a survivor’s level of fatigue, and potentially disrupt their depression, worry and anxiety and promote relaxation. By interacting with all of those pathways simultaneously, we believe YOCAS©® is a very powerful therapeutic.”
One of NCI’s research priorities is to develop effective, supportive care treatments for the toxicities and side effects experienced by cancer patients and survivors. Yoga is a very promising option – and Wilmot is at the forefront by seeking the scientific evidence to confirm that YOCAS©® works. (The proprietary therapy is protected by copyright.)
The first arm of the blinded, multicenter, Phase III trial will include volunteer cancer survivors who meet the criteria for having clinical insomnia. They will attend YOCAS©® sessions twice a week for four weeks with a trained instructor, and then develop a self-directed therapeutic practice on their own. The second arm will receive the gold-standard treatment for insomnia (CBT-I), which uses sleep restriction, stimulus control and good sleep hygiene techniques. The third arm will receive health education designed specifically for survivors who have just completed their primary cancer treatments, usually consisting of surgery, chemotherapy and/or radiation therapy. The study is seeking to enroll more than 600 people through a network of cancer clinics across the country.
Another component of the trial will look at how YOCAS©® influences the psychosocial and behavioral factors associated with sleep disturbances. Up to 90 percent of cancer survivors report some form of sleep impairment after treatment, including excessive daytime napping, difficulty falling asleep or staying asleep, and waking up too early. Insomnia is defined as having one or more of these symptoms in severe and persistent form. It is among the most distressing problems reported by cancer survivors, and can increase the likelihood of death. Researchers hypothesize that YOCAS©® can improve insomnia for up to six months after the initial therapy is completed.
“If our study is positive, we’ll have a new, viable, treatment for cancer-related insomnia,” Mustian said. “Our hope is that YOCAS©® will provide benefits to a broad group of people coping with cancer.”
Gifts to the Wilmot Cancer Institute enabled Mustian and her research team to collect some of the pilot data necessary to successfully compete for the larger NCI grant. The clinical trial is funded for five years, but Mustian is seeking additional funds to examine genetic markers in RNA/DNA samples from study participants.