The National Cancer Institute (NCI) has awarded $7 million for research led by Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine and Yale Cancer Center, to study the impact of nutrition and exercise on ovarian cancer outcomes.
It is one of four grants awarded nationally by the NCI through its Exercise and Nutrition Interventions to Improve Cancer Treatment-Related Outcomes (ENICTO) in Cancer Survivors Consortium.
“Historically, there has not been an emphasis on studying the use of exercise and healthy eating during cancer treatment. The focus on lifestyle behaviors has predominantly been in the post-treatment phase, and how to use healthy diets and exercise to prevent cancer from coming back,” said the study’s co-principal investigator Tracy Crane, Ph.D., RDN, director of lifestyle medicine and digital health in cancer survivorship and co-leader of the Sylvester’s Cancer Control Research Program. “This is the first time the NCI has made a concerted effort, with dedicated resources to better understand the role of exercise and nutrition in improving treatment outcomes, and our study will help to build this evidence. The fact that the NCI has recognized Sylvester and its diverse catchment area as a key player in answering this question is huge.”
Sylvester Comprehensive Cancer Center and Yale Cancer Center are leading the research, set to begin in June 2022. Each center will recruit 100 newly diagnosed ovarian cancer patients scheduled to receive treatment, including surgery and chemotherapy. Patients will be randomly assigned either to a medical nutrition therapy and exercise intervention that Dr. Crane helped to develop and studied, or to an attention control condition.
The intervention will be tailored to each patient, her symptoms, and where she is in her treatment journey. The five-year study’s primary outcome is to evaluate whether the intervention improves patients’ ability to tolerate and complete treatment. Sylvester researchers will look at such things as whether the intervention group has fewer adverse events from treatment, such as neuropathy, pain, depression, and anxiety. The study will also include the collection of digital biomarkers from wearable devices, to provide a more granular understanding of treatment toxicities and the impact of a nutrition and exercise intervention over the course of the treatment plan.
“We know that ovarian cancer patients have improved rates of survival if they can finish all cycles of chemotherapy,” said Dr. Crane, who also is associate professor of medicine in the Division of Medical Oncology at the Miller School. “We will be offering the trial in Spanish as well as English, in an effort to answer the question of how exercise and diet is affecting underrepresented women with ovarian cancer, including Hispanic and Black women here in South Florida.”
Cancer treatment side effects can be chronic and debilitating, not only impacting patients’ quality of life but also interfering with chemotherapy treatment dosage and compromising the success of the few options available to ovarian cancer patients, said study coinvestigator Frank J. Penedo, Ph.D., Sylvester associate director for cancer survivorship and translational behavioral sciences.
“Documenting the efficacy of an innovative lifestyle intervention for ovarian cancer survivors in reducing chemotherapy toxicities and sustaining recommended treatment dosage is highly innovative, and Sylvester is among the first cancer centers leading this trial,” said Dr. Penedo, also professor of psychology and medicine at the Miller School and the College of Arts and Sciences. “This work has the potential to shift clinical practice and promote better outcomes in a disease that continues to be the most lethal gynecologic malignancy.”
Study coinvestigator Matthew P. Schlumbrecht, M.D., M.P.H., medical co-director of the cancer survivorship program at Sylvester, said that literally all his ovarian cancer patients ask what they can do beyond treatment to improve their outcomes.
“We know, for example in other disease sites, that markers of inflammation and stress go down when people exercise. We also know that those same markers can actually promote cancer growth. By introducing exercise early, specifically during the initial treatment for ovarian cancer, we’re hoping that what we’ll see is improvement in compliance and ability to complete the initial chemotherapy regimen, which is the most important thing to try and achieve a cure,” said Dr. Schlumbrecht, who is also a professor in the Department of Obstetrics, Gynecology and Reproductive Sciences at the Miller School.
The study, according to Dr. Schlumbrecht, is a unique opportunity for Sylvester’s ovarian cancer patients to safely implement lifestyle changes at the very start of their cancer journey, which will likely have significant long-term benefits.
“The goal is that this study gives us the evidence we need to change the clinical paradigm such that when a patient comes through the door with a diagnosis of cancer, we not only hand them their prescription for traditional cancer treatment, but also one for diet and physical activity to best improve their outcomes,” Dr. Crane said.