Diversity Supplement: Dose-response of aerobic training during total neoadjuvant therapy for locally advanced rectal cancer

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PROJECT SUMMARY/ABSTRACT Randomized trials demonstrate aerobic training (AT) attenuates treatment-induced impairments in physiological and psychosocial outcomes in a broad number of cancer patient populations. However, whether AT specifically impacts the tolerability of cancer treatment is largely unknown. To address this fundamental knowledge gap in exercise-oncology research, the objective of this study is to evaluate the dose-response of AT on treatment tolerability and related outcomes in patients with locally advanced rectal cancer (LARC) initiating total neoadjuvant therapy (TNT). In this phase 2 randomized trial, a total of 216 inactive patients with LARC scheduled to initiate TNT will be randomly allocated (1:1:1 ratio) to receive: 90 mins/week, 150 mins/week, or 300 mins/week from pre-treatment to pre-surgery (~32 weeks). We will address 3 specific aims: AIM 1: Determine dose- response of AT on TNT treatment tolerability. AIM 2: Evaluate AT dose-response on hematological function. AIM 3: Explore AT dose-response on tumor clinical outcomes. The proposed study directly addresses an unmet clinical need by testing, for the first time, the dose-response effects of AT on multiple treatment-related outcomes in patients with LARC receiving TNT. Receiving cancer treatment is not a qualifying condition for exercise therapy and, as such, exercise is not currently considered a standard aspect of cancer management. Therefore, if successful, findings from this investigation will also shift clinical paradigms regarding exercise therapy in cancer by adding to a growing body of evidence supporting integration of AT into standard clinical cancer care. The overall objective of this supplemental project is to provide a post-baccalaureate research training and mentorship program for the candidate by leveraging the parent clinical trial evaluating chemotherapy tolerability in patients with LARC. The proposed research project will directly contribute to and expand the parent grant by comprehensively evaluating methods used to determine chemotherapy tolerability using relative dose intensity. This Diversity Supplement will also support a career development plan that was specifically designed around the candidate’s clinical and research interests, and is intended to provide the skills, knowledge, and experience to: (1) accomplish the scientific aims of the proposed research; (2) realize the candidate’s short term career goals of enrolling in and successfully completing medical school; and (3) achieve the candidate’s long term career goal of becoming a clinician-scientist. The aims of the supplement address the NIH goals of promoting diversity in scientific research and will strongly enhance the candidate’s career development within academic medicine, where less than 5% of individuals identify as Hispanic.