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). LARC is an ideal model in which to conduct a definitive trial of AT on treatment
tolerability for several reasons: (1) high rate of LARC diagnoses annually in the U.S. (>40,000), (2) poor
tolerability of TNT (<60% of patients complete the recommended regimen), and (3) strong biological rationale
(TNT-induced impairment in hematological function is the major cause of poor tolerability, and AT is
demonstrated to enhance hematological function in preclinical and clinical studies). Therefore, in this phase 2
randomized trial, a total of 225 inactive (<60 mins of moderate-intensity exercise/wk) patients with LARC
scheduled to initiate TNT will be stratified by sex (male vs. females) and age (<55 years vs. >55 years) and
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). All AT dose regimens will be prescribed according to standard AT principles and
implemented using our digital AT platform permitting all sessions to be performed in patients’ homes with remote
real-time monitoring. 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. The proposed study will improve behavioral intervention protocols for patients undergoing cancer treatment
by using our digital exercise approach that expands access to AT for patients not residing within close proximity
of a research site. 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.
If you are accessing this page during weekend or evening hours, the database may currently be offline for maintenance and should operational within a few hours. Otherwise, we have been notified of this error and will be addressing it immediately.
Please contact us
if this error persists.
We apologize for the inconvenience.
- The DCCPS Team.