Pilot Study of Aerobic Exercise During Immune Checkpoint Inhibitor Therapy in Early-Stage TNBC

Feasibility will be measured by adherence to both exercise frequency and time (duration/intensity) at the supervised sessions.

Change of CD8+ T cells in the peripheral blood from baseline (pre-exercise) to post-exercise state

NK cells, T regulatory (Treg) cells, markers of T cell exhaustion and immunosenescence (CD57, CD45-RA, PD1, KLRG1, CTLA-4)

peak oxygen uptake

This is a Patient-Reported Outcome to measure health-related quality of life in patients with cancer. The instrument consists of 30 items comprising five functional scales (physical, role, emotional, cognitive, and social functioning), one global health status/quality of life scale, three multi-item symptom scales (fatigue, pain, nausea/vomiting), and several single-item symptom measures (e.g., dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).Responses are scored and transfored to a 0-100 scale. Responses are scored and linearly transformed to a 0-100 scale. For functional scales and the global health status/quality of life scale, higher scores indicate better functioning or quality of life. For symptom scales and single-item measures, higher scores indicate greater symptom severity or burden.

This is a Patient-Reported Outcome to measure of quality of life patients with breast cancer. The instrument includes multi-item and single-item scales assessing domains such as systemic therapy side effects, breast and arm symptoms, body image, sexual functioning, sexual enjoyment, future perspective, and treatment-related symptoms. Scores are linearly transformed to a 0-100 scale. For functional scales (e.g., body image, sexual functioning, future perspective), higher scores indicate better functioning. For symptom scales/items (e.g., breast symptoms, systemic therapy side effects), higher scores indicate greater symptom burden or severity.

This is a Patient-Reported Outcome of multidimensional fatigue in patients with cancer. The instrument consists of 12 items evaluating physical fatigue, emotional fatigue, and cognitive fatigue, as well as the extent to which fatigue interferes with daily activities and social functioning. Responses are scored and linearly transformed to a 0-100 scale. Higher scores indicate greater fatigue severity and greater interference with functioning.

Pathologic complete response (pCR) rate

Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v 5.0)

heart rate in beats per minute

steps per day

number of active versus sedentary minutes per day

This is a self-administered instrument used to quantify frequency of leisure time physical activity during a typical 7-day period. Participants report the number of times per week they engage in activities lasting ≥15 minutes at three intensity levels: strenuous (vigorous), moderate, and light (mild). A Leisure Score Index (LSI) will be calculated using the formula: (9 × number of strenuous sessions) + (5 × number of moderate sessions) + (3 × number of light sessions). Scores reflect weighted weekly leisure-time physical activity, with higher scores indicating greater self-reported activity levels. There is no absolute maximum score; a score of 0 indicates no reported leisure-time physical activity.

Measure of functional mobility (balance, lower extremity strength, and functional capacity) through assessment of 3 components (balance test, gait speed test, and chair stand test). Each component is scored from 0-4 points, for a total score range of 0-12. Higher scores indicate better functional mobility.