Comparing Relaxation Programs for Breast Cancer Patients Receiving Radiotherapy
Name of the Trial
Biobehavioral Effects of Relaxation for Women with Breast Cancer Undergoing Radiotherapy (2009-0976; NCT01202851). See the protocol summary.
Dr. Lorenzo Cohen, University of Texas MD Anderson Cancer Center
Why This Trial Is Important
Women with early-stage breast cancer usually have surgery to remove the tumor followed by radiation therapy. Depending on the characteristics of their cancer, they may also receive systemic therapies, including chemotherapy, hormonal therapy, targeted therapy, or a combination of these, before and/or after surgery. This multimodality treatment has helped many women survive breast cancer, but the rigors of treatment can leave women with other problems that may affect their health and sense of well-being.
Breast cancer surgery can result in lingering pain and affect physical functioning and range of body movement. Systemic therapies can cause sleep disruption, reduced ability to concentrate and to remember, fatigue, peripheral neuropathy, and other complications, whereas radiation therapy may cause fatigue, tenderness or swelling in the treated area, and, in some cases, peripheral neuropathy. These side effects can greatly affect a person’s quality of life and cause stress, which may exacerbate a negative sense of well-being.
Radiation therapy following breast cancer surgery typically involves daily treatments for 4 to 6 weeks. Some doctors believe that this daily contact with patients may be an opportunity to teach them methods to reduce the severity of cancer symptoms and treatment side effects, as well as associated stress.
In this study, women with breast cancer who have had surgery and are scheduled to undergo radiation therapy will be randomly assigned to one of two different stretching and relaxation programs or to a control group that will receive usual care. Both active arms of the study will include stretching exercises, breathing exercises, and relaxation exercises. Women assigned to either of the relaxation programs will participate in 3 to 5 sessions a week for the duration of their radiation therapy and will then be asked to practice the relaxation techniques on their own every day for the following year.
All participants will complete questionnaires and 7-day sleep diaries before radiation therapy begins, midway through their radiation treatment, and during their last week of therapy, as well as at 3, 6, and 12 months after radiation treatment ends. Additionally, they will submit saliva samples before radiation therapy begins, during the last week of therapy, and at 3, 6, and 12 months after radiation treatment ends. The tests will measure levels of cortisol, a chemical in the body associated with stress, in their saliva at these different time points.
“We’ve seen from our previous research that women who participate in these types of programs throughout treatment have improvement in aspects of physical functioning and their ability to engage in daily activities,” said Dr. Cohen.
“One particularly interesting aspect of the study is that we are measuring cortisol as an indicator of stress. We know that cortisol levels vary throughout the day, usually higher in the morning and tapering off over the course of the day, and there’s evidence that a greater slope of this diurnal cortisol change is associated with better survival in patients with metastatic breast cancer. Our research indicates that women who practice mind-body relaxation programs, like yoga, tend to have steeper cortisol slopes.
“Another very important element of the study will be cost/benefit analyses between the women in each arm of the study, particularly in terms of documenting work productivity and functioning,” he explained. “We’re interested not only in whether women go to work or not, but also the degree to which they are able to focus on and be engaged in their work tasks, either outside or inside the home.”
The study is taking place at the University of Texas MD Anderson Cancer Center in Houston.