This clinical trial studies the safety of a real-time tele-exercise resistance training (training done using a tablet) in maintaining skeletal muscle, strength, physical function, and health-related quality of life in patients with pancreatic cancer who are receiving combination chemotherapy or have undergone surgery for the treatment of pancreatic cancer. Tele-exercise resistance training may improve physical function and quality of life in patients with pancreatic cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04837118.
PRIMARY OBJECTIVE:
I. Evaluate the safety of a progressive, home-based, tele-exercise resistance training (tele-RT) intervention in patients undergoing chemotherapy for localized or advanced pancreatic ductal adenocarcinoma (PDAC) (Study 1) and in survivors who have undergone pancreatic cancer resection (Study 2).
SECONDARY OBJECTIVES:
I. Evaluate the feasibility and acceptability of the tele-RT intervention.
II. Evaluate changes in the following exploratory outcome measures over the course of chemotherapy for advanced PDAC and associations between resistance training (RT) volumes and their changes:
IIa. Muscular strength
IIb. Muscular endurance
IIc. Body composition (skeletal muscle mass)
IId. Aerobic fitness
IIe. Self-reported physical activity
IIf. Self-reported physical functioning
IIg. Fatigue
IIh. Peripheral neuropathy
IIi. Health-related quality of life (QOL)
IIj. Completion of intended chemotherapy dose (Among patients who are undergoing chemotherapy; all participants in Study 1 and some in Study 2)
IIk. Exercise motivation
IIl. Exercise self-efficacy
IIm. Social support for exercise
IIn. Reduction or change in treatment plan
III. Evaluate cancer care providers’ (treating physicians and other clinical personnel) perspectives regarding the feasibility and acceptability of the tele-RT intervention for their patients.
OUTLINE:
STUDY 1: During the first 2-3 months of chemotherapy, patients complete at least 4 tele-RT sessions over 30-45 minutes each, every 2 weeks. Patients receive handouts created by MD Anderson Cancer Center (MDACC) clinical dietitians including individualized recommendations for daily protein intake and information about healthy protein supplementation during chemotherapy. Patient may also attend a visit with a registered dietician (or delegate dietician) per standard of care, if they have renal insufficiency, special dietary needs, or difficulty adhering to protein recommendations.
STUDY 2: After standard of care surgical resection, patients complete at least 4 tele-RT sessions over 30-45 minutes each, every 2 weeks for 2-3 months. Patients receive handouts created by MDACC clinical dietitians including individualized recommendations for daily protein intake and information about healthy protein supplementation during chemotherapy. Patient may also attend a visit with a registered dietician (or delegate dietician) per standard of care, if they have renal insufficiency, special dietary needs, or difficulty adhering to protein recommendations.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorKaren M. Basen-Engquist