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Cancer Metastatic to LiverPOET-mCRCNCT05579340

Postoperative Exercise Training and Colorectal Cancer Liver Metastasis

A study testing Exercise in people with Cancer Metastatic to Liver and Cancer Colorectal, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Up to 25% of colorectal cancer (CRC) patients are diagnosed with liver metastases, which is the most common site of metastasis, already during the primary tumor diagnosis. Another 30% of the patients will develop liver metastases at a later stage. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer Metastatic to Liver, Cancer Colorectal
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteDenmark
Study dates
18 Apr 2023to Jun 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

  • Colorectal cancer patients diagnosed with liver metastasis and scheduled for liver metastasis surgical resection

Who cannot join

  • Age <18
  • Pregnancy
  • Physical or mental disabilities that prohibit execution of test or training procedures
  • Inability to understand the Danish language.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Rigshospitalet (CFAS)

    Copenhagen, 2100

Other trials in Denmark

About this study

Official title: Post-Operative Exercise Training in Patients With Metastatic Colorectal Cancer

Up to 25% of colorectal cancer (CRC) patients are diagnosed with liver metastases, which is the most common site of metastasis, already during the primary tumor diagnosis. Another 30% of the patients will develop liver metastases at a later stage. Even though patient can be treated by surgical resection of the metastatic tumor, 50-75% of the patients experience a relapse in less than two years. Due to the high probability of relapse, mCRC patients undergo multiple rounds of surgery and adjuvant treatment (chemotherapy/radiotherapy) which results in substantial physical de-conditioning.

Physical activity has been shown to increase the progression-free survival rates in mCRC patients, when applied post-diagnosis. Increased cardiorespiratory fitness (VO2peak) at the time of diagnosis among CRC individuals has been associated with lower risk of all-cause mortality. Although data on the effect of chronic exercise on VO2peak have emerged, thus far, there is no randomized clinical trial that has investigated the effects of exercise training in mCRC patients early after surgical treatment with curative intent.

Read more

Therefore, this project aims to address the beneficial effect of structured exercise training primarily on VO2peak and tumor recurrence in mCRC patients immediately after surgical treatment and while they are undergoing adjuvant chemotherapy/radiotherapy.

A total of 66 participants will be recruited from the Department of Surgery and Transplantation, Rigshospitalet and randomly allocated to a standard care control group (n=22), standard care plus 150 min/week exercise training (n=22) or standard care plus 300 min/week exercise training (n=22). Participants will undergo exercise training for 6 months, starting immediately after surgery, and they will be followed for additional 6 months. Tumor recurrence will be evaluated up to 3 years after training initiation.

Being tested
Exercise
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    6 months of combined aerobic and resistance exercise

Study groups in NCT05579340
Study groupRoleWhat they receive
Usual careNo interventionNot described
Ex1ExperimentalLow exercise volume (150 min/week)
Receives: Other: Exercise
Ex2ExperimentalHigh exercise volume (300 min/week)
Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in peak oxygen consumption (VO2peak)

    Changes in VO2peak assessed during an incremental exercise test to volitional exhaustion on a bicycle ergometer

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

Secondary outcomes (62)

  1. 3-years recurrence-free survival

    Proportion of patients who survive without relapse (formation of new tumors) for the 3-year period

    Measured: Randomization to 3 years after randomization

  2. 3-years overall survival

    Proportion of patients who are alive 3 years after randomization

    Measured: Randomization to 3 years after randomization

  3. Changes in Aerobic Capacity: Ventilatory threshold

    Changes in ventilatory threshold assessed during an incremental exercise test to volitional exhaustion on a bicycle ergometer

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  4. Changes in Aerobic Capacity: Peak power output

    Changes in peak power output assessed during an incremental exercise test to volitional exhaustion on a bicycle ergometer

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  5. Changes in Muscle strength: Hand grip strength

    Changes in hand grip strength, assessed using a dynamometer

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  6. Changes in Muscle strength: Leg press maximal muscle strength

    Changes in leg press one repetition maximum (1RM)

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  7. Changes in Functional performance: Habitual gait speed

    Changes in habitual gait speed

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  8. Changes in Functional performance: Maximal gait speed

    Changes in maximal gait speed

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  9. Changes in Functional performance: Stair climbing performance

    Changes in time required to climb a specific staircase

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  10. Changes in Functional performance: 30 seconds Sit-to-stand

    Changes in the number of stands from sitting position that can be performed during 30 seconds

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  11. Changes in Body composition and anthropometrics: Body mass

    Changes in body mass

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  12. Changes in Body composition and anthropometrics: Total lean mass

    Changes in total lean mass assessed by dual energy x-ray absorptiometry (DXA)

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  13. Changes in Body composition and anthropometrics: Total fat mass

    Changes in total fat mass assessed by DXA

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  14. Changes in Body composition and anthropometrics: Bone mineral density

    Changes in bone mineral density assessed by DXA

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  15. Changes in Body composition and anthropometrics: Waist circumference

    Changes in waist circumference

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  16. Changes in Body composition and anthropometrics: Hip circumference

    Changes in Hip circumference

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  17. Changes in Systolic Blood pressure

    Changes in resting systolic blood pressure

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  18. Changes in Diastolic Blood pressure

    Changes in resting diastolic blood pressure

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  19. Changes in Heart rate

    Changes in resting heart rate

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  20. Changes in Blood biochemistry: leukocyte differential counts

    Changes in resting leukocyte differential counts (total and per type [eosinophils, basophils, lymphocytes, monocytes, neutrophils])

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  21. Changes in Blood biochemistry: C-reactive protein

    Changes in resting C-reactive protein levels in blood

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  22. Changes in Blood biochemistry: Insulin

    Changes in resting insulin blood levels

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  23. Changes in Blood biochemistry: Glucose

    Changes in resting glucose blood levels

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  24. Changes in Blood biochemistry: Triglycerides

    Changes in resting triglycerides blood levels

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  25. Changes in Blood biochemistry: LDL-Cholesterol

    Changes in resting LDL-cholesterol blood levels

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  26. Changes in Blood biochemistry: HDL-Cholesterol

    Changes in resting HDL-cholesterol blood levels

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  27. Changes in Cytokine levels in blood: Interleukin-6

    Changes in resting Interleukin-6 blood levels

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  28. Changes in Cytokine levels in blood: Interleukin-1

    Changes in resting Interleukin-1 blood levels

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  29. Changes in Cytokine levels in blood: Interleukin-7

    Changes in resting Interleukin-7 blood levels

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  30. Changes in Cytokine levels in blood: Interleukin-8

    Changes in resting Interleukin-8 blood levels

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  31. Changes in Cytokine levels in blood: Interleukin-15

    Changes in resting Interleukin-15 blood levels

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  32. Changes in Cytokine levels in blood: Interleukin-1β

    Changes in resting Interleukin-1β blood levels

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  33. Changes in Cytokine levels in blood: Interleukin-10

    Changes in resting Interleukin-10 blood levels

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  34. Changes in Cytokine levels in blood: Tumor-necrosis-factor alpha (TNFalpha)

    Changes in resting TNFalpha blood levels

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  35. Changes in Cytokine levels in blood: Interferon gamma (IFN-gamma)

    Changes in resting IFN-gamma blood levels

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  36. Changes in Immune cells in blood: Natural killer (NK) cells

    Changes in resting NK cells

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  37. Changes in Immune cells in blood: CD4 T cells

    Changes in resting CD4 T cells

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  38. Changes in Immune cells in blood: CD8 T cells

    Changes in resting CD8 T cells

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  39. Changes in Immune cells in blood: B cells

    Changes in resting B cells

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  40. Changes in Osteonectin

    Changes in resting osteonectin blood levels

    Measured: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

  41. Changes in Patient-reported symptomatic adverse events

    Patient-reported symptomatic adverse events, assessed using the using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    Measured: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation

  42. Changes in Health-related quality of life: Physical well-being

    Changes in patient-reported physical well-being assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) (scale scoring 0-28, the higher the score the better quality of life)

    Measured: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation

  43. Changes in Health-related quality of life: Social well-being

    Changes in patient-reported social well-being assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) (scale scoring 0-28, the higher the score the better quality of life)

    Measured: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation

  44. Changes in Health-related quality of life: Emotional well-being

    Changes in patient-reported emotional well-being assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) (scale scoring 0-24, the higher the score the better quality of life)

    Measured: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation

  45. Changes in Health-related quality of life: Functional well-being

    Changes in patient-reported functional well-being assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) (scale scoring 0-28, the higher the score the better quality of life)

    Measured: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation

  46. Changes in Health-related quality of life: General

    Changes in patient-reported general health-related qualify of life assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) (scale scoring 0-108, the higher the score the better quality of life)

    Measured: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation

  47. Changes in Health-related quality of life: Colorectal cancer specific

    Changes in patient-reported colorectal-cancer specific health-related quality of life assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) (scale scoring 0-28, the higher the score the better quality of life)

    Measured: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation

  48. Changes in Health-related quality of life: total score

    Changes in patient-reported in health-related quality of life (total score) assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) (scale scoring 0-136, the higher the score the better quality of life)

    Measured: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation

  49. Changes in Health-related quality of life: Trial outcome index

    Changes in patient-reported trial outcome index assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) (scale scoring 0-84, the higher the score the better quality of life)

    Measured: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation

  50. Changes in Health-related quality of life: Fatigue

    Changes in patient-reported fatigue assessed using the Functional Assessment of Cancer Therapy - Fatigue scale (FACIT-Fatigue) (scale score: 0-52, the higher the score the less fatigue)

    Measured: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation

  51. Changes in Depression

    Changes in patient-reported depression, assessed using the Hospital Anxiety and Depression Scale (HADS) (scale scoring: 0-21, the higher the score the worse the condition)

    Measured: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation

  52. Changes in Anxiety

    Changes in patient-reported anxiety, assessed using the Hospital Anxiety and Depression Scale (HADS) (scale scoring: 0-21, the higher the score the worse the condition)

    Measured: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation

  53. Changes in Physical activity: Walking

    Changes in patient-reported weekly duration of walking, assessed using the International Physical Activity Questionnaire (IPAQ)

    Measured: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation

  54. Changes in Physical activity: Moderate intensity physical activity

    Changes in patient-reported weekly duration of moderate intensity physical activity, assessed using the International Physical Activity Questionnaire (IPAQ)

    Measured: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation

  55. Changes in Physical activity: Vigorous intensity physical activity

    Changes in patient-reported weekly duration of vigorous intensity physical activity, assessed using the International Physical Activity Questionnaire (IPAQ)

    Measured: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation

  56. Changes in Physical activity: Total intensity physical activity

    Changes in patient-reported weekly duration of total intensity physical activity, assessed using the International Physical Activity Questionnaire (IPAQ) (Expressed as metabolic equivalent (MET)-min per week: MET level x minutes of activity x events per week)

    Measured: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation

  57. Changes in Physical activity: sitting time

    Changes in patient-reported weekly sitting time, assessed using the International Physical Activity Questionnaire (IPAQ)

    Measured: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation

  58. Changes in Circulating tumor DNA (ctDNA)

    Changes in ctDNA in blood

    Measured: Baseline, 6-, and 12 months after exercise training initiation

  59. Changes in DNA methylation

    Changes in DNA methylation derived from blood

    Measured: Baseline, 6-, and 12 months after exercise training initiation

  60. Changes in treatment tolerance: Relative dose intensity (RDI) of adjuvant chemotherapy

    RDI (%) of adjuvant chemotherapy, calculated as the actual dose intensity / standard dose intensity x 100%

    Measured: From date of planned initiation to end of adjuvant chemotherapy

  61. Postoperative hospital admissions

    Incidence of postoperative hospital re-admissions, defined as any non-scheduled ≥ 24 h hospitalization

    Measured: From discharge to 12 months after exercise training initiation

  62. Postoperative complications

    Incidence of postoperative complications up to 30 days after surgery (total and by grade and type), assessed using the Clavien-Dindo classification

    Measured: From discharge to 30 days after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2022
  2. Study start18 Apr 2023
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

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
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05579340
Sponsor's protocol ID
POET-mCRC
Acronym
POET-mCRC
Status last verified
Feb 2026
First submitted
22 Sep 2022
Last updated
24 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Cancer Metastatic to Liver and Cancer Colorectal, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

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 1 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in peak oxygen consumption (VO2peak) (time frame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05579340.

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 24 Feb 2026.

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