Colorectal CancercrEATeNCT07922850
Tailored Nutrition vs. Exercise Prehabilitation Before Colorectal Cancer Surgery
A study testing Tailored Nutritional Counselling and Physiotherapist-Guided Exercise Programme in people with Colorectal Cancer and Colorectal Neoplasms, run by University Hospital of North Norway at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colorectal Neoplasms
- What is being tested?
- Tailored Nutritional Counselling and Physiotherapist-Guided Exercise Programme
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Dec 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites
Nordland Hospital Trust
Bodø
Kåre Nordland, Kare.Ragnar.Nordland@nordlandssykehuset.no
Martin Iversen Hagve, +4777626447, martin.iversen.hagve@unn.no
University Hospital of North Norway
Tromsø
Martin Iversen Hagve, +4777626447, martin.iversen.hagve@unn.no
About this study
Official title: ColoREctal Cancer Surgery and Multimodal pREhabilitation Assessing Tailored Nutrition vs. Exercise - An Open Label Superiority Multicenter Randomized Controlled Trial.
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.
Read the detailed description
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.
- Conditions
- Colorectal Cancer, Colorectal Neoplasms
- Being tested
- Tailored Nutritional Counselling, Physiotherapist-Guided Exercise Programme
- Keywords
- Prehabilitation, Nutritional Support, Exercise
- Medical subject headings
- Colorectal Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Nutritional CounsellingBehavioural
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.
Physiotherapist-Guided Exercise ProgrammeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | 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 Intervention | Experimental | 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. Receives: Behavioral: Tailored Nutritional Counselling |
| Multimodal Prehabilitation | Experimental | 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. Receives: Behavioral: Tailored Nutritional Counselling; Behavioral: Physiotherapist-Guided Exercise Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 30 days after surgery
Secondary outcomes (11)
Change in Handgrip Strength
Maximal isometric handgrip strength measured in kilograms using a hand dynamometer, as an indicator of muscle strength.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 30 days after surgery
Length of Hospital Stay
Total number of days from date of surgery to date of hospital discharge.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline and 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- UiT The Arctic University of Norway, Nordlandssykehuset HF, Asker & Baerum Hospital
- Responsible party
- Principal investigator, Martin Iversen Hagve, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922850
- Sponsor's protocol ID
- 1001278
- Acronym
- crEATe
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to patient confidentiality. Parts of the data set may be available on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ColoREctal Cancer Surgery and Multimodal pREhabilitation Assessing Tailored Nutrition vs. Exercise - An Open Label Superiority Multicenter Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07922850
- Acronym / sponsor ID
- crEATe / 1001278
- Conditions
- Colorectal Cancer, Colorectal Neoplasms
- Keywords
- Prehabilitation, Nutritional Support, Exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- UiT The Arctic University of Norway, Nordlandssykehuset HF, Asker & Baerum Hospital
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –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 Intervention | Experimental | Behavioral: Tailored Nutritional CounsellingParticipants 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. |
| Multimodal Prehabilitation | Experimental | Behavioral: Tailored Nutritional Counselling, Behavioral: Physiotherapist-Guided Exercise ProgrammeParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored Nutritional CounsellingIndividualised 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. | Behavioural | Multimodal Prehabilitation, Tailored Nutritional Intervention |
| Physiotherapist-Guided Exercise ProgrammeStructured, 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. | Behavioural | Multimodal Prehabilitation |
Primary outcome
Change in 6-Minute Walk Test Distance
Time frame: Baseline and 30 days after surgery
Distance walked (in metres) during a standardised 6-minute walk test, a validated measure of functional exercise capacity.
11 secondary outcomes
Change in Handgrip Strength
Time frame: Baseline and 30 days after surgery
Change in 30-Second Chair Stand Test (30s-CST)
Time frame: Baseline and 30 days after surgery
Change in Nutritional Intake
Time frame: Baseline, end of preoperative intervention period (up to 5 weeks), and 30 days after surgery
30-Day Hospital Readmission Rate
Time frame: Within 30 days after surgery
Rate of Severe Postoperative Complications
Time frame: Within 30 days after surgery
Length of Hospital Stay
Time frame: From date of surgery to date of hospital discharge, up to 30 days
Change in Nutritional Risk Screening (NRS-2002) Score
Time frame: Baseline and end of preoperative intervention period (up to 5 weeks)
Change in Clinical Frailty Scale Score
Time frame: Baseline and end of preoperative intervention period (up to 5 weeks)
Change in Health-Related Quality of Life (EQ-5D-5L)
Time frame: Baseline and 30 days after surgery
Postoperative Quality of Recovery (QoR-15)
Time frame: Baseline and 30 days after surgery
Change in Cancer-Specific Quality of Life (EORTC QLQ-C30)
Time frame: Baseline and 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Nutritional Counselling and Physiotherapist-Guided Exercise Programme in people with Colorectal Cancer and Colorectal Neoplasms, run by University Hospital of North Norway at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Iversen Hagve, MD, PhD (+4777626447, martin.iversen.hagve@unn.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6-Minute Walk Test Distance (time frame: Baseline and 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.