An interventional study of Tailored Nutritional Counselling and Physiotherapist-Guided Exercise Programme in Colorectal Cancer and Colorectal Neoplasms, sponsored by University Hospital of North Norway. Not yet recruiting at 2 sites in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by University Hospital of North Norway · Not applicable, Interventional, and Supportive care
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.
Hypothesis: Tailored preoperative nutritional therapy in a regular clinical setting improves postoperative functional capacity, and while nutritional intervention alone may improve surgical outcome, multimodal prehabilitation combining nutrition and exercise provides additional benefit, particularly improvement in physical function.
Design: This is a three-armed, open-label, multicentre, parallel-group randomized controlled superiority trial comparing standard of care, tailored nutritional intervention alone, and multimodal prehabilitation (nutrition plus structured exercise) in patients undergoing elective colorectal cancer surgery. Participants are allocated 1:1:1 using a computer-generated randomization sequence with randomly permuted block sizes, stratified by study site, nutritional risk (NRS-2002) and clinical frailty score. Data are collected at three time points: baseline (first surgical consultation), after completion of the preoperative intervention (preferably the day before surgery), and approximately 30 days after surgery.
Interventions: The nutrition intervention consists of individualised dietary counselling from a clinical dietitian, targeting a protein intake of 1.2-1.5 g/kg/day, supplemented as needed with oral nutritional supplements. The multimodal prehabilitation intervention adds a structured, physiotherapist-guided home exercise programme (aerobic and resistance training, 3 times weekly) to the nutrition intervention. The intervention period reflects the normal clinical waiting time to surgery, limited to a minimum of 2 and a maximum of 5 weeks.
Sample size: Based on pilot data and power calculations from the dHOPE study in the same patient population, using a standard deviation for change in 6-minute walk test of 43 metres, alpha=0.05 and 80% power, 40 evaluable patients per group are needed. Allowing for an estimated 15% combined screen failure and dropout, a total of 140 patients will be enrolled.
Statistics: Analyses will follow the intention-to-treat principle. The primary endpoint will be analysed using a linear mixed-effects model including treatment group, time and the group-by-time interaction, adjusted for baseline 6-minute walk test and the stratification variables. Continuous secondary outcomes will be analysed with similar mixed models; binary outcomes with logistic regression.
Retrospective substudy: A separate substudy will assess body composition and nutritional status retrospectively, based on routinely acquired preoperative abdominal CT scans and available clinical data, in order to calculate whether participants meet the Global Leadership Initiative on Malnutrition (GLIM) criteria for malnutrition and to explore associations between body composition, nutritional status, functional reserve, and postoperative outcomes. No additional CT scans are performed for study purposes, and results do not influence clinical treatment during the study.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 140 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →University Hospital of North Norway is the lead sponsor of 152 studies on the registry; 24 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients undergoing elective colorectal cancer surgery who give and meet all of the following will be eligible:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Behavioral: Tailored Nutritional Counselling
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.
Behavioral: Tailored Nutritional Counselling · Behavioral: Physiotherapist-Guided Exercise Programme
Individualised dietary counselling delivered by a clinical dietitian, beginning with a baseline nutritional assessment. Target protein intake is set at 1.2-1.5 g/kg/day, with oral nutritional supplements or protein powder used when dietary intake alone is insufficient. Includes weekly follow-up with weight measurement and adjustment of nutritional advice from inclusion until 30 days postoperatively.
Structured, physiotherapist-guided exercise programme combining aerobic and resistance training three times per week, with intensity individually adjusted using the Borg scale. Participants keep an exercise diary and receive weekly follow-up from a physiotherapist from inclusion until 30 days postoperatively.
Change in 6-Minute Walk Test Distance
Distance walked (in metres) during a standardised 6-minute walk test, a validated measure of functional exercise capacity.
Time frame: Baseline and 30 days after surgery
Change in Handgrip Strength
Maximal isometric handgrip strength measured in kilograms using a hand dynamometer, as an indicator of muscle strength.
Time frame: Baseline and 30 days after surgery
Change in 30-Second Chair Stand Test (30s-CST)
Lower-extremity muscle strength and endurance assessed using the 30-Second Chair Stand Test (30s-CST): the number of complete sit-to-stand repetitions performed in 30 seconds from a standard-height chair without armrests, with arms crossed over the chest. The score is a count of repetitions with a minimum value of 0 and no fixed maximum; higher values indicate better lower-extremity physical function. Results can be compared with published age- and sex-specific reference values.
Time frame: Baseline and 30 days after surgery
Change in Nutritional Intake
Daily energy (kcal/kg/day) and protein (g/kg/day) intake, assessed using dietary records or recall.
Time frame: Baseline, end of preoperative intervention period (up to 5 weeks), and 30 days after surgery
30-Day Hospital Readmission Rate
Proportion of participants readmitted to hospital within 30 days after surgery.
Time frame: Within 30 days after surgery
Rate of Severe Postoperative Complications
Proportion of participants experiencing severe postoperative complications. Complications are classified using the Clavien-Dindo classification, which grades postoperative complications from Grade I (any deviation from normal recovery not requiring specific treatment) to Grade V (death); severe complications are defined as Grade IIIb or higher, i.e. complications requiring intervention under general anesthesia, or life-threatening complications (including organ dysfunction) requiring intensive/critical care management.
Time frame: Within 30 days after surgery
Length of Hospital Stay
Total number of days from date of surgery to date of hospital discharge.
Time frame: From date of surgery to date of hospital discharge, up to 30 days
Change in Nutritional Risk Screening (NRS-2002) Score
Nutritional risk assessed using the Nutritional Risk Screening 2002 (NRS-2002) tool, ranging from a minimum value of 0 and a maximum value of 7. A score of 3 or more indicates the patient is nutritionally at-risk and a nutritional care plan should be initiated; a score below 3 indicates the patient is not currently at nutritional risk.
Time frame: Baseline and end of preoperative intervention period (up to 5 weeks)
Change in Clinical Frailty Scale Score
Frailty status assessed using the Clinical Frailty Scale (CFS), a 9-point judgement-based scale ranging from a minimum value of 1 and a maximum value of 9. A score of 1 indicates a very fit patient, and a score of 9 indicates a terminally ill patient; higher scores indicate increasing frailty, with a score of 5 or above generally considered indicative of clinically significant frailty.
Time frame: Baseline and end of preoperative intervention period (up to 5 weeks)
Change in Health-Related Quality of Life (EQ-5D-5L)
Health-related quality of life measured using the EQ-5D-5L questionnaire. The descriptive system covers 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each scored from a minimum value of 1 (no problems) to a maximum value of 5 (extreme problems/unable), which can be combined into a single index value. The EQ Visual Analogue Scale (EQ VAS) records self-rated overall health from a minimum value of 0 (the worst health you can imagine) to a maximum value of 100 (the best health you can imagine).
Time frame: Baseline and 30 days after surgery
Postoperative Quality of Recovery (QoR-15)
Postoperative recovery quality assessed using the 15-item Quality of Recovery score (QoR-15), ranging from a minimum value of 0 and a maximum value of 150. Higher scores indicate better quality of postoperative recovery.
Time frame: Baseline and 30 days after surgery
Change in Cancer-Specific Quality of Life (EORTC QLQ-C30)
Cancer-specific health-related quality of life measured using the EORTC QLQ-C30 questionnaire. Raw scores for each functional scale, symptom scale, and the global health status/QoL scale are linearly transformed to a minimum value of 0 and a maximum value of 100. Higher scores on the functional scales and the global health status/QoL scale indicate better functioning/quality of life, whereas higher scores on the symptom scales indicate greater symptom burden.
Time frame: Baseline and 30 days after surgery
Retrospective Assessment of Malnutrition per GLIM Criteria
As part of a separate retrospective substudy, skeletal muscle mass will be quantified from routinely acquired preoperative abdominal CT scans (L3 level) using body composition software, where such scans are clinically available. No additional CT scans will be performed for study purposes and results will not influence clinical treatment. Findings will be used to determine whether participants meet the GLIM criteria for malnutrition.
Time frame: Retrospective analysis after study completion, using CT scans obtained ≤4 weeks before or within 1 week after inclusion as part of routine clinical care
Plan to share: No — IPD will not be shared due to patient confidentiality. Parts of the data set may be available on reasonable request.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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