Tailored Nutrition vs. Exercise Prehabilitation Before Colorectal Cancer Surgery
NCT07922850, Not applicable, Not yet recruiting, University Hospital of North Norway
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Tailored Nutrition vs. Exercise Prehabilitation Before Colorectal Cancer Surgery | ClinicalTrials.gov |
| NCT number | NCT07922850 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 140 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University Hospital of North Norway | ClinicalTrials.gov |
| Conditions | Colorectal Cancer, Colorectal Neoplasms | ClinicalTrials.gov |
| Interventions | Tailored Nutritional Counselling, Physiotherapist-Guided Exercise Programme | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in 6-Minute Walk Test Distance | Baseline and 30 days after surgery | Distance walked (in metres) during a standardised 6-minute walk test, a validated measure of functional exercise capacity. | ClinicalTrials.gov |
| Secondary | Change in Handgrip Strength | Baseline and 30 days after surgery | Maximal isometric handgrip strength measured in kilograms using a hand dynamometer, as an indicator of muscle strength. | ClinicalTrials.gov |
| Secondary | Change in 30-Second Chair Stand Test (30s-CST) | Baseline and 30 days after surgery | 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. | ClinicalTrials.gov |
| Secondary | Change in Nutritional Intake | Baseline, end of preoperative intervention period (up to 5 weeks), and 30 days after surgery | Daily energy (kcal/kg/day) and protein (g/kg/day) intake, assessed using dietary records or recall. | ClinicalTrials.gov |
| Secondary | 30-Day Hospital Readmission Rate | Within 30 days after surgery | Proportion of participants readmitted to hospital within 30 days after surgery. | ClinicalTrials.gov |
| Secondary | Rate of Severe Postoperative Complications | Within 30 days after surgery | 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. | ClinicalTrials.gov |
| Secondary | Length of Hospital Stay | From date of surgery to date of hospital discharge, up to 30 days | Total number of days from date of surgery to date of hospital discharge. | ClinicalTrials.gov |
| Secondary | Change in Nutritional Risk Screening (NRS-2002) Score | Baseline and end of preoperative intervention period (up to 5 weeks) | 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. | ClinicalTrials.gov |
| Secondary | Change in Clinical Frailty Scale Score | Baseline and end of preoperative intervention period (up to 5 weeks) | 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. | ClinicalTrials.gov |
| Secondary | Change in Health-Related Quality of Life (EQ-5D-5L) | Baseline and 30 days after surgery | 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). | ClinicalTrials.gov |
| Secondary | Postoperative Quality of Recovery (QoR-15) | Baseline and 30 days after surgery | 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. | ClinicalTrials.gov |
| Secondary | Change in Cancer-Specific Quality of Life (EORTC QLQ-C30) | Baseline and 30 days after surgery | 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. | ClinicalTrials.gov |
| Other | Retrospective Assessment of Malnutrition per GLIM Criteria | Retrospective analysis after study completion, using CT scans obtained ≤4 weeks before or within 1 week after inclusion as part of routine clinical care | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)