Can a 4-Week Pre-Surgery boost cut complications in GI cancer surgery?
NCT ID NCT06404489
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a 4-week program of exercise, nutrition advice, and stress management before major gastrointestinal cancer surgery can reduce serious complications within 30 days after the operation. About 400 adult patients scheduled for elective GI cancer surgery will take part. The program is tailored to each patient's needs and aims to improve their physical and mental readiness for surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Multimodal prehabilitation program (exercise, nutrition optimization, and distress-coping techniques)
- What this could lead to
- If it works, this could reduce serious complications and shorten hospital stays for people undergoing major gastrointestinal cancer surgery.
- What could go wrong
- This is a single-center study with 400 participants, and the program is tailored individually, so results may not apply to all patients or hospitals. The intervention is behavioral, so adherence and effectiveness can vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * All adult patients (age \> 18 years) scheduled for elective gastrointestinal surgery for cancer. * Signed informed consent Exclusion Criteria: Co-morbid medical, physical, and mental conditions interfering with the ability to complete study procedures, such as: * acute or unstable cardio-respiratory conditions (e.g., unstable angina or symptomatic severe aortic stenosis) * severe/end-stage organ diseases (e.g., cardiac failure NYHA functional classes III-IV, COPD FEV1 \<50% pred, end-stage kidney or liver disease); * American Society of Anesthesiologists (ASA) physical status classes 4-5. * disabling orthopedic and neuromuscular disease. * psychosis, dementia; * symptomatic anemia. * Pregnancy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Azienda Ospedaliera Universitaria
Cagliari, Sardinia, Italy
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IRCCS San Raffaele Scientific Institute
Milan, 20132, Italy
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Other studies related to the condition(s) this trial covers.
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