Sylvester Comprehensive Cancer Center Launches Clinical Trial on Fasting for Endometrial Cancer
Summary
- Endometrial cancer diagnoses and deaths are climbing, largely driven by obesity and metabolic health challenges.
- Sylvester Comprehensive Cancer Center’s Dr. Tracy Crane and Dr. Matthew Schlumbrecht have launched a new clinical trial, FIT-ENDO.
- The FIT-ENDO trial is testing prolonged overnight fasting, which aligns food intake with the body’s natural circadian rhythms and can improve blood sugar control and reduce the production of cancer-promoting hormones.
At Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine, a team of physicians, research scientists and trainees is uniting behind a bold idea to combat endometrial cancer. The idea? Change when patients eat, not just what they eat. It’s a simple schedule change with potentially profound biological effects.
Endometrial cancer diagnoses and deaths are climbing nationwide, largely driven by obesity and metabolic health challenges. Each year, nearly 68,000 women in the U.S. are diagnosed with endometrial cancer, which affects the lining of the uterus.
To reverse that trend, Tracy Crane, Ph.D., RDN, co-leader of the Cancer Control Program at Sylvester and assistant professor in the Miller School’s Division of Medical Oncology, and Matthew Schlumbrecht, M.D., M.P.H., co-lead of Sylvester’s Gynecologic Oncology Site Disease Group and professor in the Miller School’s Division of Gynecological Oncology, have launched a new clinical trial, FIT-ENDO (Fasting InTervention for Endometrial Cancer).
Dr. Crane, the study’s principal investigator, and co-principal investigator Dr. Schlumbrecht are leading the first-of-its-kind clinical trial, along with a team of trainees, physicians and scientists. The researchers aim to improve cancer outcomes with an approach that could transform care for women before and after endometrial cancer surgery.
“Obesity and metabolic syndrome are driving up rates of endometrial cancer,” said Dr. Crane, director of lifestyle medicine, prevention and digital health at Sylvester. “We need innovative, accessible strategies that can help women improve their health and cancer outcomes.”
The Science Behind FIT-ENDO: Fasting for Better Cancer Outcomes
The FIT-ENDO trial is testing an intervention called prolonged overnight fasting (POF), which asks women to stop eating by 8 p.m. and fast for at least 12 hours overnight, gradually increasing to 14 hours. This approach aligns food intake with the body’s natural circadian rhythms, which can improve blood sugar control and reduce the production of cancer-promoting hormones.
“Emerging evidence shows that meal timing can impact metabolism, hormone levels and even tumor growth,” said Dr. Schlumbrecht. “By guiding patients through a fasting routine before surgery, we hope to see improvements in metabolic markers and quality of life.”
The trial will enroll 42 women scheduled for endometrial cancer surgery at Sylvester, Jackson Memorial Hospital, Jupiter Medical Center and Advent Health in Orlando. Participants are randomly assigned to either the fasting intervention or an attention control group receiving standard care and educational materials. Researchers will track changes in blood sugar, insulin and hundreds of metabolites, as well as patient-reported outcomes such as sleep and well-being.
The FIT-ENDO study is a true team science effort. Trainees and research staff help recruit and support patients. Physicians oversee clinical care. Scientists lead the intervention, analyzing tissue and blood samples for changes in gene and protein expression. The trial will use telehealth coaching with My Wellness Research, continuous glucose and activity monitors and materials in English, Spanish and Haitian Creole to reach all patients in the study.
“Our goal is to improve cancer outcomes for all women with this intervention,” said Dr. Crane, associate professor at the Miller School. “We’re building a statewide consortium for gynecologic oncology research, connecting community hospitals and academic centers.”
Florida Cancer Innovation Fund: Fuel for Rapid Progress
The FIT-ENDO trial is one of many projects energized by the Florida Cancer Innovation Fund (FCIF), a $60 million initiative launched by the Florida Department of Health. The fund supports innovative cancer research, clinical trials and prevention strategies across the state, with a focus on rapid, high-impact results. Dr. Crane and her team received $557,637 from the fund. The team includes Sylvester researchers:
• David Lombard, M.D., Ph.D., professor of pathology and laboratory medicine at the Miller School
• Sophia George, Ph.D., associate professor of obstetrics, gynecology and reproductive sciences at the Miller School
• Andre Pinto, M.D., associatte professor of pathology and laboratory medicine at the Miller School
• Melissa Lopez-Pentacost, Ph.D., RDN, a Sylvester post-doctoral research fellow
FCIF encourages collaboration among oncologists, researchers and cancer centers and prioritizes projects that can deliver measurable improvements in patient care within 12 months. The fund also supports nutrition-based prevention research and repurposing generic drugs for cancer treatment.
What’s Next: Research and Impact
If successful, the FIT-ENDO trial could pave the way for larger studies and new guidelines for meal timing in cancer care. The Sylvester team plans to use results from this pilot to apply for major grants from the National Cancer Institute to expand fasting interventions to more patients and cancer types.
“Lifestyle interventions like fasting are low-cost, scalable and can be delivered at home,” said Dr. Crane. “They have the potential to improve outcomes not just for endometrial cancer, but for other hormone-related cancers as well.”
Tags: Dr. Andre Pinto, Dr. David Lombard, Dr. Matthew Schlumbrecht, Dr. Melissa Lopez-Pentacost, Dr. Sophia George, Dr. Tracy Crane, endometrial cancer, fasting, lifestyle medicine, Newsroom, Sylverster Comprehensive Cancer Center