A current clinical trial seeks to determine whether decreasing weight and increasing exercise after a breast cancer diagnosis can reduce a woman's risk of disease recurrence.
The Breast Cancer Weight Loss (BWEL) trial (NCT02750826), sponsored by the NCI and the Alliance for Clinical Trials in Oncology and led by Dana-Farber Cancer Institute, is a multiyear trial testing the impact of a weight-loss program on the risk of breast cancer recurrence in women who are overweight or obese when they are diagnosed with breast cancer. Fitbit technology is being used in the study to monitor weight-loss goals and physical activity and to help motivate patients to make changes in their exercise and diet patterns.
“We know that there is a link between obesity and breast cancer. Studies show that these are both risk factors for developing breast cancer and for poor outcomes in women with the disease,” said Jennifer Ligibel, MD, a medical oncologist at the Dana-Farber Cancer Institute in Boston. “We wanted to know, how can we intervene?”
Ligibel, also Associate Professor at Harvard Medical School, specializes in caring for women with breast cancer. Over the last decade, her research has focused on the connection between body weight and physical activity, and the risk of developing breast cancer or a recurrence of the disease.
The randomized phase III trial investigates whether exercise and weight loss in overweight and obese women can prevent breast cancer recurrence. Previous studies suggest that women who carry excess weight when diagnosed with breast cancer face a greater risk of recurrence than women who are not overweight or obese.
Specifically, the trial measures the impact of a supervised weight-loss intervention on invasive disease-free survival in overweight (BMI 27-29.9 kg/m2) and obese (BMI ≥30kg/m2) women diagnosed with HER-2 negative, stage II and III breast cancer.
The BWEL trial includes two cohorts. The first will undergo telephone-based coaching and supervised weight-loss information and health educational materials. The second will receive only health educational materials. In the interventional group, patients speak with a health coach weekly for the first 12 weeks, and bi-weekly thereafter for the rest of the year. In the second year of the trial, they speak with coaches monthly. Thereafter, data is collected annually from participants through the end of the 10-year trial.
“The trial provides more support up front to build people's self-efficacy,” Ligibel said. “Hopefully by the time they reach the end of the 2-year intervention period, they have tools that enable them to become their own coaches.”
According to the American Cancer Society, approximately 20 percent of women treated for breast cancer each year experience a recurrence of the disease, with most of those women developing metastatic breast cancer.
Other similar studies investigate how helping patients engage in physical activity and weight loss can improve quality of life or fitness. Most of those, Ligibel noted, are on a much smaller scale than the ongoing BWEL clinical trial—and patients are enrolled in one or two centers rather than nationwide.
The BWEL clinical trial includes a wide cross section of patient demographic, from those living in large urban areas to rural or small-town communities.
“The virtual nature of this trial allows researchers to gain a more accurate representation of breast cancer survivors by enrolling a more diverse population from regions across the country,” Ligibel noted, “enabling patients living in more rural areas to participate.”
Since August 2016, the trial has enrolled more than 1,700 patients in communities across the U.S. and Canada. To date, the trial has enrolled patients from 49 states and five Canadian provinces. Results are expected in 2024. In addition to coaching, a Fitbit tracker, and smart scale, participants have access to protein meal replacement shakes, an online calorie-counting program, and meal-planning resources.
Participant Liz M., of the intervention-based group, credits her progress to the BWEL clinical trial.
“The structure, support, and encouragement I receive help immensely,” Liz said. “You change what you're doing. I might think I've been active today, but then I see that I am 3,000 steps away from my goal. You are accountable for what you're trying to achieve. If you live alone like I do, you especially have to be self-started. All of the tools I have through the trial are very useful for that.”
Diagnosed with stage IIIa breast cancer in June 2016 and already overweight, Liz had a bilateral modified radical mastectomy and axillary lymph node dissection. She underwent 12 weeks of chemotherapy and 35 radiation treatments.
“I finished treatment in the end of January 2017. To date, there is no evidence of disease,” she said. So far, she has lost 15-20 pounds—about halfway to her target weight.
“I am happy to take part in this trial. I think the research will help other women. I am thrilled to personally be at a place where I am making better food choices, eating healthier, and continuing to lose weight—to be as healthy as I can going forward,” Liz noted. “I might not have achieved the improved level of health I have now if I hadn't gotten serious about the program.”
Karin Lillis is a contributing writer.