This clinical trial evaluates a resistance exercise intervention with or without protein supplementation for the enhancement of skeletal muscle mass in patients undergoing chemotherapy treatment for pancreatic cancer that has not spread to other places in the body (non-metastatic). Exercise is a non-pharmacologic strategy for improving health outcomes in cancer survivors, but this approach remains largely unexplored among pancreatic cancer patients, particularly with the inclusion of a nutrition supplement component like protein supplementation. Post-exercise protein supplementation can be used to enhance muscle mass production. Resistance exercise intervention with protein supplementation may work better for patients with pancreatic cancer undergoing chemotherapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05356117.
Locations matching your search criteria
United States
Massachusetts
Boston
Dana-Farber Cancer InstituteStatus: Active
Contact: Christina Dieli-Conwright
Phone: 617-582-8321
PRIMARY OBJECTIVE:
I. To evaluate the feasibility of conducting a virtually supervised resistance exercise (RE) intervention combined with daily protein supplementation (PS) for non-metastatic pancreatic cancer patients initiating chemotherapy.
SECONDARY OBJECTIVES:
I. To evaluate the effects of a RE intervention with and without PS on the skeletal muscle mass in non-metastatic pancreatic cancer patients receiving chemotherapy.
II. To evaluate the effects of a RE intervention with and without PS on the plasma biomarkers associated with tissue wasting in non-metastatic pancreatic cancer patients receiving chemotherapy.
III. To evaluate the effects of a RE intervention with and without PS on physical function and psychosocial measures in non-metastatic pancreatic cancer patients receiving chemotherapy.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive a virtually-supervised home-based resistance exercise intervention via Zoom over 60 minutes 3 times a week for up to 16 weeks.
ARM II: Patients receive a virtually-supervised home-based resistance exercise intervention via Zoom over 60 minutes 3 times a week and receive protein supplementation daily for up to 16 weeks.
ARM III: Patients perform stretching exercises 3 times a week for up to 16 weeks.
Patients also undergo computed tomography (CT) scans and collection of blood samples at baseline and post-intervention.
After completion of study treatment, patients may be followed up for 4 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorChristina Dieli-Conwright
