Multimodal Exercise before Surgery in Improving Quality of Life in Participants with Pancreatic Cancer

PRIMARY OBJECTIVES:

I. To compare the change between the time of enrollment and completion of preoperative therapy in the six minute walk test (6MWT) distance of patients with pancreatic cancer who are scheduled to receive preoperative chemotherapy and/or radiation prior to anticipated pancreatectomy and who are offered a stretching program plus general recommendations to remain active during preoperative therapy (standard care).

II. To compare the change between the time of enrollment and completion of preoperative therapy in the six minute walk test (6MWT) distance of patients with pancreatic cancer who are scheduled to receive preoperative chemotherapy and/or radiation prior to anticipated pancreatectomy and who are offered a stretching plus structured exercise program and behavioral skills training during preoperative therapy.

SECONDARY OBJECTIVES:

I. To compare physical function (patient-reported based on the Patient Reported Outcomes Measurement Information System [PROMIS] Physical Function Short Form and objectively based on the 5 times sit-to-stand test, arm curl test, gait speed via the 3 meter walk test, and grip strength) between groups.

II. To compare the Quality of Life (Functional Assessment of Cancer Therapy-Hepatobiliary [FACT-Hep]) between groups.

III. To compare exercise motivation (Behavioral Regulation in Exercise Questionnaire [BREQ]-3) between groups.

IV. To compare levels of circulating tumor-associated and angiogenic factors (CA 19-9, thrombospondin) between groups upon enrollment, following administration of preoperative therapy, and at postoperative visits scheduled 3-6 weeks and 3-7 months following discharge.

V. To compare tumor vascular structures between groups (among patients who have undergone surgical resection).

VI. To compare anthropometric measures (e.g., skeletal muscle, visceral fat and subcutaneous fat) using SliceOMatic Software and usual care computed tomography (CT) scans between groups.

VII. To assess the change in nutrition status (Patient-Generated Subjective Global Assessment short form [PGSGAsf]) along all study time points in all enrolled participants. Also, to correlate the PGSGAsf score with the corresponding anthropometric measures at each time point for all participants.

VIII. To assess the incidence of perioperative adverse events that occur within 90 days between groups (Accordion score).

IX. To compare the 6MWT distance and secondary endpoints of participants within subgroups of patients who are stratified as “active” versus “insufficiently active” based on the Godin-Shephard Leisure Time Physical Activity Questionnaire.

X. To compare the 6MWT distance and secondary endpoints of participants within subgroups of patients with different levels of physical activity (light, moderate, high intensity activity).

XI. To examine differences among Fitbit-measured physical activity and sleep between groups and associations among Fitbit variables and secondary endpoints between and within groups.

XII. To evaluate feasibility of patient completion of 24-hour dietary recall via Automated Self-Assisted 24-hour recall (ASA-24).

XIII. To evaluate the associations between exercise activity (from Fitbit-measured activity and self-reported from the Godin) and survival outcomes (progression-free survival, overall survival, recurrence-free survival).

XIV. To evaluate the associations between physical function measures at baseline (T0)/changes (T1-T0)/preoperatively (T1) and survival outcomes (progression-free survival, overall survival, recurrence-free survival).

XV. To explore validated cachexia measures and their associations with physical function, exercise activity, and survival outcomes (progression-free survival, overall survival, recurrence-free survival).

OUTLINE: Participants are randomized into 1 of 2 arms.

ARM A: Participants receive standard of care and remain active during chemotherapy and/or radiation therapy.

ARM B: Participants complete moderate-intensity aerobic exercise over up to 30 minutes for at least 5 days per week. Participants also complete strength training exercises at least 2 times per week and complete 1 set of 10-15 repetitions for each of the 8 exercises that are taught.