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

Conditions

• Gastrointestinal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• structured treadmill walking — BEHAVIORAL
  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 throughout treatment.

Study Details

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.

Key Dates

Start date

Apr 28, 2023

Status verified

Apr 2026

Primary completion

Mar 1, 2027

Completion

Apr 18, 2027

Study Design

Enrollment

216 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• 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 chemotherapy. 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 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.
• 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 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.

Primary Outcome Measure

proportion of patients achieving (ratio of delivered to planned treatment) RDI ≥ 90% [ Time Frame: 5 years ]

Central Contacts

• Jessica Scott, PhD
  646-888-8103
  [email protected]
• Andrea Cercek, MD
  646-888-4189

Locations (8)

Find similar trials in Hartford, CT

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