This phase Ib trial tests the feasibility of a health care provider (HCP) guided exercise intervention prior to surgery in improving surgical outcomes in patients with pancreatic cancer who have completed prior neoadjunvant chemotherapy. Pancreatic cancer is a leading cause of cancer death in the United States. This cancer is often treated with chemotherapy and surgery. Exercise may help subjects with cancer by improving their function and reducing side effects of treatment and cancer. In some situations, it is possible that physical exercise will have an impact on the body’s immune system and this may change tumors. This trial may help researchers identify how to design a HCP guided exercise programs for patients with pancreatic cancer who are going to surgery and identify whether this kind of intervention will have a beneficial effect on tumors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05483075.
PRIMARY OBJECTIVE:
I. To determine the feasibility of a HCP guided exercise intervention prior to surgery in pancreatic cancer subjects who have completed prior neoadjunvant chemotherapy.
SECONDARY OBJECTIVES:
I. To determine the safety of a HCP guided exercise intervention.
II. To assess changes in anti-tumor immunity, as measured by the number of tumor infiltrating CD8+ T cells, as well as markers of CD8 T cell activation such as interleukin 15 receptor alpha subunit (IL-15Ra) and granzyme B (GZMB) expression, after a HCP exercise intervention by comparing changes within each subject (blood and tumor) and between intervention and observational control arm and publicly available published or presented data for pancreatic cancer subjects.
III. To assess the impact of a HCP guided exercise intervention on objective measures of physical activity and sleep including duration time spent in sedentary behavior, time spent in MPVA (moderate to vigorous physical activity), time in rapid eye movement (REM) sleep, average daily metabolic equivalent (MET) rates, and estimated physical activity energy expenditure by comparing intervention with observational control arm.
EXPLORATORY OBJECTIVES:
I. Evaluate the risk of cancer recurrence and survival based on study intervention and tumor immune properties.
II. Evaluate patient reported outcomes including fatigue, as measured by the Multidimensial Fatigue Symptom Inventory.
OUTLINE: Participants are assigned to 1 of 2 groups.
GROUP I (EXERCISE): Participants undergo the HCP guided exercise regimen consisting of moderate aerobic and strength exercises for a minimum of 30 minutes 5 days a week, with 2 days per week under HCP supervision on study. Participants wear an actigraph centrepoint insight watch to monitor activity. Participants also undergo collection of blood and tumor biopsy on study.
GROUP II (CONTROL): Participants wear an actigraph centrepoint insight watch to monitor activity. Participants also undergo collection of blood and tumor biopsy on study.
Trial PhasePhase I
Trial Typesupportive care
Lead OrganizationLaura and Isaac Perlmutter Cancer Center at NYU Langone
Principal InvestigatorPaul Eliezer Oberstein
