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NCT07922850
Tailored Nutrition vs. Exercise Prehabilitation Before Colorectal Cancer Surgery
Conditions: Colorectal Cancer, Colorectal Neoplasms
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 140
Sponsor: University Hospital of North Norway
Location: Nordland Hospital Trust Bodø
Summary
This study will test whether tailored nutritional support before surgery, alone or combined with a structured exercise program, can help adult patients recover better after surgery for colorectal (bowel) cancer. Participants will be randomly assigned to one of three groups: usual care, tailored nutritional support alone, or nutritional support combined with a structured exercise program (multimodal prehabilitation). The main goal is to find out whether either approach improves physical function 30 days after surgery, measured by how far participants can walk in 6 minutes (the 6-minute walk test). The study will also look at nutritional intake, physical function, quality of life, complications, hospital readmissions, and length of hospital stay. A total of 140 adult patients scheduled for surgery for colorectal cancer at hospitals in Northern Norway will be enrolled.
Eligibility Criteria
Inclusion Criteria:
Patients undergoing elective colorectal cancer surgery who give informed consent and meet all of the following will be eligible:
* Planned elective surgery for colorectal cancer
* Age \>=18 years
* If neoadjuvant treatment has been given, treatment must be completed and the patient must be scheduled for surgery
* Able to understand Norwegian sufficiently to receive study information, complete questionnaires, and follow written and oral instructions
* Able and willing to provide written informed consent
Exclusion Criteria:
* Known metastatic disease
* Previous participation in structured multimodal prehabilitation as part of the current cancer treatment pathway before inclusion, for example during neoadjuvant therapy
* Previous major gastrointestinal surgery considered by the treating clinician to substantially affect the planned colorectal cancer surgery or postoperative recovery
* Physical impairment that prevents the participant from walking for six minutes or rising independently from a chair
* Planned multivisceral resection and/or complex reconstruction due to locally advanced cancer
* Ongoing severe nutritional support, such as parenteral nutrition, that limits the feasibility of the allocated intervention
* Cognitive impairment that prevents the participant from understanding the intervention, exercise programme, questionnaires, or written and oral instructions
* Severe comorbidity or other medical condition that, in the judgement of the treating clinician, precludes participation in structured exercise
* Severe renal failure, including patients requiring dialysis or with clinically significant electrolyte disturbances
* Inability to use the telemedicine technology required for follow-up when telemedicine-based follow-up is planned
* No permanent address or expected hospital/institutional stay for more than 50% of the time between diagnosis and planned surgery
Source: ClinicalTrials.gov (NCT07922850). StuddyBuddy aggregates publicly available trial information.