PRIMARY OBJECTIVE:
I. To determine the dose-response of aerobic training (AT) on chemotherapy tolerability, defined as the proportion of patients receiving chemotherapy who achieve a relative dose intensity for chemotherapy (relative dose intensity [RDI]; ratio of delivered to planned treatment) of >= 90%.
SECONDARY OBJECTIVES:
I. To compare chemotherapy RDI (on a continuous scale, %) between AT dose cohorts.
II. To compare the proportion of patients achieving RDI >= 90% using first chemotherapy regimen prescribed by the treating oncologist only (i.e., first regimen RDI).
III. To compare the proportion of patients achieving RDI >= 90% across all chemotherapy agents and radiation (i.e., chemo-radiation RDI).
IV. To compare incidence of chemotherapy discontinuation (i.e., treatment permanently discontinued prior to scheduled end), delay (i.e., treatment delayed by >= 1 week), reduction (i.e., treatments requiring dose reduction), and toxicities as assessed by rate of grade 1-5 adverse events.
V. To compare supportive care pharmacotherapy as assessed by dose, type, and length of supportive pharmacotherapies.
VI. To compare patient-reported outcomes and self-reported diet.
VII. To evaluate AT dose-response on hematological function as evaluated by changes in hematological profile (e.g., neutrophil count, hemoglobin) and function (e.g., hematopoietic stem / progenitor cells [HSPCs] differentiation, neutrophil apoptosis).
VIII. To compare AT safety and adherence.
IX. To compare AT pharmacodynamics as evaluated by changes in physiological (e.g., cardiorespiratory fitness, body composition, blood pressure, heart rate, grip strength) and diet correlates.
EXPLORATORY OBJECTIVES:
I. To explore AT dose-response on tumor response as evaluated by pathologic complete response (pCR) rate, clinical complete response (cCR) rate, and disease-free survival (DFS) and progression free survival (PFS) rates.
II. To explore clinical and physiological factors associated with AT adherence and chemotherapy tolerability.
III. To explore surgical tolerability as assessed by 30-day post-operative events and length of hospital stay.
IV. To explore tumor regrowth as defined as any sign of tumor recurrence.
V. To explore the association between AT adherence and tolerability.
VI. To collect and bank stool specimens for future analyses.
VII. To collect and bank blood specimens for future analyses.
VIII. To explore change in waist to hip ratio circumference.
IX. To explore effects of AT dose within each tumor type.
X. To explore adaptations made to the protocol.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients complete 90 minutes of structured treadmill walking per week for the duration of their standard of care (SOC) treatment. Patients undergo blood sample collection and sub-maximal exercise tolerance test throughout the study. Patients may also undergo stool sample collection on study and during follow-up.
ARM II: Patients complete 150 minutes of structured treadmill walking per week for the duration of their SOC treatment. Patients undergo blood sample collection and sub-maximal exercise tolerance test throughout the study. Patients may also undergo stool sample collection on study and during follow-up.
ARM III: Patients complete 300 minutes of structured treadmill walking per week for the duration of their SOC treatment. Patients undergo blood sample collection and sub-maximal exercise tolerance test throughout the study. Patients may also undergo stool sample collection on study and during follow-up.
Patients are followed up at 3 weeks after the last walking session, prior to surgery and then up to the end of the entire study period (5 years).
