A Study on the Effects of Exercise on Side Effects From Treatment for Rectal Cancer

Overview

The purpose of this study is to find the level of aerobic exercise (AT) that is practical, is safe, and has positive effects on the body that may reduce the side effects of Total Neoadjuvant Therapy (TNT). The study will also look at the way the body responds to exercise and whether there are differences in TNT treatment. This will include looking at the highest TNT treatment dose participants receive, how many people stop, delay, or reduce the treatment, and whether additional medication is needed to treat side effects of TNT.

Full Title of Study: “Dose-response of Aerobic Training During Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 2028

Interventions

  • Behavioral: structured treadmill walking
    • Three doses of AT (i.e., 90, 150, or 300 mins/week) will be tested. All doses will consist of individualized walking delivered up to 7 times per week delivered from TNT initiation until surgery (~32 weeks).

Arms, Groups and Cohorts

  • Experimental: 90 min/wk
    • AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 1: 90 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during TNT. Supervised AT will be monitored using TeleEx.
  • Experimental: 150 mins/wk
    • AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 1: 90 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during TNT. Supervised AT will be monitored using TeleEx.
  • Experimental: 300 mins/wk
    • AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 1: 90 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during TNT. Supervised AT will be monitored using TeleEx.

Clinical Trial Outcome Measures

Primary Measures

  • proportion of patients achieving (ratio of delivered to planned treatment) RDI ≥ 90%
    • Time Frame: 5 years
    • RDI (%) will be calculated as the ratio of delivered to planned dose intensity (delivered dose intensity/planned dose intensity).

Participating in This Clinical Trial

Inclusion Criteria

  • Aged ≥18 years – Diagnosed with locally advanced rectal cancer as defined by one of the following: – Histological confirmation – As per standard of care imaging – Scheduled to receive TNT – Performing ≤90 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report – Willingness to comply with all study-related procedures – Cleared for exercise participation as per screening clearance via the Physical Activity Readiness Questionnaire Exclusion Criteria:

  • Enrollment onto any other interventional investigational study, except interventions determined by the PI not to confound study outcomes – Receiving treatment for any other diagnosis of invasive cancer – Distant metastatic malignancy of any kind – Mental impairment leading to inability to cooperate – Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Memorial Sloan Kettering Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jessica Scott, PhD, Principal Investigator, Memorial Sloan Kettering Cancer Center
  • Overall Contact(s)
    • Jessica Scott, PhD, 646-888-8103, scottj1@mskcc.org

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