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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥18 years

Histological confirmation

As per standard of care imaging

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

216 Participants
are divided into 3 treatment groups
Group A: 90 min/wkExperimental treatment 1 intervention
Group B: 150 mins/wkExperimental treatment 1 intervention
Group C: 300 mins/wkExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

proportion of patients achieving (ratio of delivered to planned treatment) RDI ≥ 90%

RDI (%) will be calculated as the ratio of delivered to planned dose intensity (delivered dose intensity/planned dose intensity).

Time frame
5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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