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Can lifestyle interventions such as exercise and intermittent fasting help patients with advanced breast cancer better tolerate side effects from treatment?
That is the question Tracy Crane, PhD, RDN, and Carmen Calfa, MD, at Sylvester Comprehensive Cancer Cente at the University of Miami Miller School of Medicine and their collaborators will strive to answer with a $4-million, five-year grant from the National Cancer Institute (NCI).
Crane, co-lead of Cancer Control and director of Lifestyle Medicine, Prevention and Digital Health at Sylvester, is multiple principal investigator, along with Christina Dieli-Conwright, PhD, and Jennifer Ligibel, MD, from Dana Farber Cancer Institute. Calfa, medical co-director of Cancer Survivorship and Translational Behavioral Sciences at Sylvester, is co-investigator for this phase II, randomized trial, which will include 260 women with advanced breast cancer.
The trial is being conducted in English and Spanish and focuses on women starting a CDK4/6 inhibitor medication in combination with hormonal therapy. Researchers hypothesize that the prolonged overnight fasting with and without exercise during daylight hours will help with alignment of circadian activity rhythms and ultimately improve levels of fatigue. Circadian activity rhythms include sleep/wake cycles and physical activity and disruption of these significantly disturbs homeostasis of a variety of biological and metabolic processes including immune function, cellular aging and death.
Crane said it will build on a recently completed pilot study among 30 women with advanced breast cancer demonstrating that prolonged overnight fasting, a type of intermittent fasting, and exercise interventions were well tolerated and led to reduced fatigue and improved quality of life.
“We know from previous studies of patients with early breast cancer that lifestyle interventions can reduce fatigue, improve physical function and lessen the impact of other treatment-related side effects,” Crane said. “However, there are few studies and limited data about the impact of exercise and dietary interventions on patients living with advanced breast cancer.”
About 300,000 new cases of invasive breast cancer are diagnosed every year and about 40,000 women die of metastatic disease, even though treatment for breast cancer has improved significantly in recent years.
“Although patients are living longer than ever with advanced breast cancer, newer targeted therapies can cause significant side effects, including fatigue, decreased immune defense as well as gastrointestinal symptoms,” Calfa explained. “Additionally, hormonal treatments used in combination with targeted therapies can result in menopausal symptoms, mood disorders and impaired sleep.
“For some patients, the side effects can become debilitating, resulting in them discontinuing treatment and subsequently compromising their oncological outcome,” she added. “Empowering women with lifestyle interventions that allow them to take charge and drive a positive outcome is essential and I’m delighted to take part in this important project.”
In this study, researchers will evaluate the effectiveness of supervised exercise and prolonged overnight fasting, alone or in combination, on fatigue, biomarkers of inflammation, sleep quality, physical function, body composition and patient-reported outcomes related to depression, anxiety and quality of life versus those in an attention-control supportive care group.
Outcomes will be assessed 12 weeks after patients enroll in the trial and then again at six and 12 months.
Crane believes the trial’s timing is fortuitous for women living with advanced breast cancer.
“Our research has the potential to improve treatment tolerability, quality of life and possibly life duration for women living with advanced breast cancer,” Crane said. “Those are the most meaningful outcomes for these women.”
Enrollment in the study is anticipated to open in early 2024.
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