This trial studies the effects of exercise, along with adequate nutrition, on recovery, quality of life, and outcomes related to survival in patients who have undergone or will be undergoing surgical removal of pancreatic cancer. Diet and exercise intervention may help doctors measure reasons why patients may or may not be able to follow exercise or diet recommendations.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03187028.
PRIMARY OBJECTIVES:
I. Determine feasibility of a randomized controlled trial (RCT) in pancreatic cancer patients comparing the effects of diet alone with diet + exercise on pancreatic cancer-related functional and disease outcomes.
SECONDARY OBJECTIVES:
I. Determine preliminary effect sizes within and between groups for functional outcomes (Eastern Cooperative Oncology Group [ECOG] performance scale, objective physical functioning, self-reported quality of life [QOL]).
II. Collecting exploratory data related to within and between group differences for pancreatic cancer survival rates, recurrence rates, CA 19-9 (pancreatic cancer biomarker), serum cytokines, deoxyribonucleic acid (DNA) methylation and gut microbiome in pancreatic cancer patients receiving diet versus diet + exercise intervention.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive weekly nutrition counseling from a registered dietician by telephone, internet, or in person over 30-60 minutes for 6 months.
GROUP II: Patients receive weekly counseling from a registered dietician and an exercise trainer by telephone, internet, or in person over 30-60 minutes for 6 months. Patients also complete aerobic and resistance exercise intervention consisting of moderate intensity exercise gradually increasing to 150 minutes per week, 2-3 weekly sessions of resistance exercise, and toning/stretching on days other exercise is performed.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Alabama at Birmingham Cancer Center
Principal InvestigatorLaura Quillian Rogers