This clinical trial examines a home-based exercise “prehabilitation” program for improving physical fitness and performance in patients undergoing treatment for esophageal cancer that occurs within the esophagus and extends into adjacent areas including lymph nodes (locoregional). Muscle loss is frequently accelerated in cancer patients as a result of their disease and treatment. Maintaining a positive physical performance status improves a patient's tolerance to therapies before surgery and readiness to undergo complex operations. Exercise guidelines for cancer patients include both aerobic exercise and resistance training, and the latter is particularly critical for maintaining skeletal muscle and physical functioning. A home-based exercise prehabilitation program may improve physical fitness and performance status, thereby accelerating post-operative recovery and improving quality of life and treatment outcomes in patients with esophageal cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06430346.
Locations matching your search criteria
United States
Florida
Tampa
Moffitt Cancer CenterStatus: Active
Contact: Nathan H. Parker
Phone: 813-745-6849
PRIMARY OBJECTIVE:
I. Evaluate the feasibility and acceptability of physical activity (PA) and resistance training (RT) exercise prehabilitation components among patients preparing for LEC resection.
EXPLORATORY OBJECTIVES:
I. Examine changes in exploratory outcomes (e.g., bodyweight and body composition, aerobic and muscular fitness, physical functioning, readiness for surgery, frailty, biomarkers, quality of life [QOL]) over the course of exercise prehabilitation and recovery in these measures following therapy.
II. Compare clinical and treatment outcomes (e.g., weight and body composition, readiness for surgery, frailty, biomarkers, postoperative length of stay, surgical complications, adjuvant therapy) to those of a retrospectively identified comparison group that received no formal exercise prehabilitation programming.
OUTLINE:
Patients participate in home-based, virtually-supervised RT sessions over 30-45 minutes each twice per week and are encouraged to increase their daily step counts by 10% each week for 5-11 weeks during their standard of care (SOC) treatment. Patients who are eligible for surgery after clinical re-staging continue RT sessions and increased daily step counts for an additional 4-6 weeks prior to surgery. Patients also wear a Fitbit on study.
After completion of study intervention, patients are followed up at 3 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorNathan H. Parker
