A Study on the Effects of Exercise on Side Effects From Treatment for Gastrointestinal Cancers

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 2

Conditions: Gastrointestinal Cancer

Treatments: Behavioral: structured treadmill walking

Study type: Interventional

Funder types: Other

Identifiers

NCT05789485

22-164

Details and patient eligibility

About

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 therapy. The study will also look at the way the body responds to exercise and whether there are differences in treatment. This will include looking at the highest treatment dose participants receive, how many people stop, delay, or reduce the treatment, and whether additional medication is needed to treat side effects of therapy.

Full description

Study staff will also confirm remote training feasibility including items such as access to Wi-Fi and a treadmill for the study duration. During the feasibility assessment, if the participant is determined to not have access to Wi-Fi, we will offer a tablet with cellular capabilities. If patients do not have access to a treadmill, ExOnc staff may coordinate access to a fitness facility local to the participant, to facilitate treadmill access for the study duration. Fitness facility access will be provided through Wellhub, a service that allows use of nearby gyms and studios through a single app- based solution.

Enrollment: 216 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged ≥18 years

• Diagnosed with colorectal or esophago/gastric solid tumors as defined by one of the following:

  • Histological confirmation
  • As per standard of care imaging

• Scheduled to receive neoadjuvant chemotherapy or chemotherapy for newly diagnosed metastatic disease

• 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 lifestyle interventional investigational study, except interventions determined by the PI not to confound study outcomes
• Receiving treatment for any other diagnosis of invasive cancer
• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 3 patient groups

90 min/wk

Experimental group

Description:

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 chemotherapy. Supervised AT will be monitored using TeleEx.

Treatment:

Behavioral: structured treadmill walking

150 mins/wk

Experimental group

Description:

AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 2: 150 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 chemotherapy. Supervised AT will be monitored using TeleEx.

Treatment:

Behavioral: structured treadmill walking

300 mins/wk

Experimental group

Description:

AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 3: 300 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 chemotherapy. Supervised AT will be monitored using TeleEx.

Treatment:

Behavioral: structured treadmill walking