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Még nem keres résztvevőt itt: NorvégiaFázis nélkül

Tailored Nutrition vs. Exercise Prehabilitation Before Colorectal Cancer Surgery

A legfontosabb adatok

Ki végzi
University Hospital of North Norway
Hol
Bodø és Tromsø (Norvégia)Mind a 2 helyszín megnézése
Azonosító
Állapot
Toborzás még nem indult
Résztvevők
140 fő, tervezett
Kezdés
2026. dec. 1.
Várható befejezés
2028. aug.
A vizsgálat típusa
Beavatkozással járó, 3 csoportAz egyik csoport nem kap vizsgálati kezelést, összehasonlításként.
A vizsgált kezelések
  • Tailored Nutritional Counselling
  • Physiotherapist-Guided Exercise Programme
A regiszteradat frissítve
2026. november 12.

Ki vehet részt

Életkor
18 év felett
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 17 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

  • 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
  • No permanent address or expected hospital/institutional stay for more than 50% of the time between diagnosis and planned surgery
  • Known metastatic disease
  • 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
  • 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
  • Ongoing severe nutritional support, such as parenteral nutrition, that limits the feasibility of the allocated intervention
  • Inability to use the telemedicine technology required for follow-up when telemedicine-based follow-up is planned

Helyszínek itt: Norvégia

  • Nordland Hospital TrustBodø, NorvégiaContact: Kåre NordlandNo longer taking part
  • University Hospital of North NorwayTromsø, NorvégiaContact: Martin Iversen HagveNo longer taking part

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A vizsgálat 3 csoportja

  • Standard of CareNincs vizsgálati kezelés, összehasonlításként

    Participants receive standard of care: routine preoperative and perioperative management according to local hospital procedures and current national guidelines. No study-specific nutritional or exercise intervention is provided in this arm.

  • Tailored Nutritional InterventionA vizsgált kezelés

    Participants receive a structured nutritional intervention led by a clinical dietitian, targeting a protein intake of 1.2-1.5 g/kg/day through individualised dietary counselling, oral nutritional supplements or protein powder when needed, and enteral/parenteral nutrition when clinically indicated, per ESPEN guidelines. Weekly dietitian follow-up is provided from inclusion until 30 days postoperatively. No structured exercise programme is provided in this arm.

    Kezelés: Tailored Nutritional Counselling

  • Multimodal PrehabilitationA vizsgált kezelés

    Participants receive the same tailored nutritional intervention as the Tailored Nutritional Intervention arm, combined with an individualised, physiotherapist-guided exercise programme comprising moderate-intensity aerobic exercise and resistance training three times weekly. Participants keep an exercise diary and receive weekly physiotherapist follow-up from inclusion until 30 days postoperatively, alongside the dietitian-led nutritional follow-up.

    Kezelés: Tailored Nutritional Counselling és Physiotherapist-Guided Exercise Programme

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
ColoREctal Cancer Surgery and Multimodal pREhabilitation Assessing Tailored Nutrition vs. Exercise - An Open Label Superiority Multicenter Randomized Controlled Trial
A regiszteradat frissítve
2026. november 12.