This clinical trial evaluates the impact of a remote prehabilitation exercise and nutritional program in pancreatic patients before surgery. Patients with pancreatic cancer tend to be older adults with age-related skeletal muscle loss. Skeletal muscle loss can be accelerated due to cancer and cancer treatment related issues. Low and loss of skeletal muscle are related to adverse outcomes and quality of life after surgery. Prehabilitation is a process of improving functional capability of a patient prior to a surgical procedure to improve recovery. Resistance training (RT) is a physical exercise that uses weight or other forms of resistance to build muscle strength and size. Participating in a prehabilitation exercise and nutritional program with RT may improve outcomes and quality of life in pancreatic patients undergo surgery.
Additional locations may be listed on ClinicalTrials.gov for NCT06423963.
Locations matching your search criteria
United States
Florida
Tampa
Moffitt Cancer CenterStatus: Active
Contact: Nathan H. Parker
Phone: 813-745-6849
PRIMARY OBJECTIVES:
I. Evaluate the feasibility and acceptability of physical activity (PA)/nutritional (N) and RT/N programs among patients preparing for pancreatic cancer (PC) resection.
II. Examine exploratory outcomes (e.g., weight and body composition, aerobic and muscular fitness, physical functioning, nutritional status, quality of life [QOL]) and clinical characteristics (e.g., postoperative length of stay, surgical complications, receipt of adjuvant therapy) among PA/N and RT/N participants.
III. Compare clinical and treatment outcomes (e.g., weight and body composition, serum albumin,
postoperative length of stay, surgical complications, receipt of adjuvant therapy) between study participants and a retrospectively-identified, usual care comparison group.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive nutritional counseling once monthly and encouragement to increase daily steps weekly for up to 3 months. Patients also wear a Fitbit to monitor activity and log food on study.
ARM II: Patients receive nutritional counseling once monthly and encouragement to increase daily steps weekly for up to 3 months. Patients also receive RT equipment and participate in RT sessions over 30 minutes twice weekly for up to 3 months. Patients also wear a Fitbit to monitor activity and log food on study.
After completion of study intervention, patients are followed up preoperatively and up to 3-4 months postoperatively.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorNathan H. Parker
