Can lifestyle interventions such as exercise and intermittent fasting help patients with advanced breast cancer better tolerate the side effects of treatment?
That’s the question that scientists at the Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine and their collaborators are hoping to answer with a $4 million study conducted over five years. Head of the National Cancer Institute (NCI) in the USA.
This is a randomized phase II study in which 260 women with advanced breast cancer will take part. The study will be conducted in English and Spanish and will focus on women starting treatment with CDK4/6 inhibitors in combination with hormone therapy. The researchers’ hypothesis is: prolonged fasting overnight with and without exercise during the day will help balance circadian activity rhythms and ultimately improve fatigue levels. Circadian activity rhythms include sleep/wake cycles and physical activity, and their disruption significantly disrupts the homeostasis of various biological and metabolic processes, such as immune function, cellular aging, and death.
Crane noticed this is based on a pilot study recently conducted on 30 women with advanced breast cancer It showed that prolonged overnight fasting, a type of intermittent fasting, and physical exercise were well tolerated and led to less fatigue and an improved quality of life.
“We know from previous studies in patients with early-stage breast cancer that lifestyle interventions can reduce fatigue, improve physical function, and reduce the impact of other treatment-related side effects,” the researchers say. “However, there are few studies and limited data on the effects of exercise and nutritional interventions in patients with advanced breast cancer.”
Each year, approximately 300,000 new cases of invasive breast cancer are diagnosed and approximately 40,000 women die from metastatic disease, although breast cancer treatment has improved significantly in recent years.
Although patients with advanced breast cancer are living longer than ever before, newer targeted therapies can cause significant side effects such as fatigue, reduced immunity and gastrointestinal distress. Additionally, hormonal treatments combined with targeted therapies can cause menopausal symptoms, mood disorders, and sleep disorders.
“For some patients,” the researchers added, “side effects may become debilitating, leading them to discontinue treatment, thereby compromising their oncologic outcome.” “It is important to empower women with lifestyle interventions that enable them “To take responsibility and achieve a positive result, and I am pleased to be involved 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, inflammatory biomarkers, sleep quality, physical function, body composition, and patient-reported outcomes. in terms of depression, anxiety and quality of life compared to those in a controlled care supportive care group.
Results will be evaluated 12 weeks after patients enter the study and again at six and 12 months. Since October is Breast Cancer Awareness Month, researchers believe the study comes at an opportune time for women with advanced breast cancer.