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Active, Not Recruiting

NCT Number: NCT05579340

Postoperative Exercise Training and Colorectal Cancer Liver Metastasis

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.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cancer Metastatic to Liver Cancer Colorectal Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet (CFAS)

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Exercise

Other

6 months of combined aerobic and resistance exercise

Primary outcomes

  1. Change in peak oxygen consumption (VO2peak)

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

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

Secondary outcomes

  1. 3-years recurrence-free survival

    Time frame: Randomization to 3 years after randomization

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

  2. 3-years overall survival

    Time frame: Randomization to 3 years after randomization

    Proportion of patients who are alive 3 years after randomization

  3. Changes in Aerobic Capacity: Ventilatory threshold

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

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

  4. Changes in Aerobic Capacity: Peak power output

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

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

  5. Changes in Muscle strength: Hand grip strength

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

    Changes in hand grip strength, assessed using a dynamometer

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

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

    Changes in leg press one repetition maximum (1RM)

  7. Changes in Functional performance: Habitual gait speed

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

    Changes in habitual gait speed

  8. Changes in Functional performance: Maximal gait speed

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

    Changes in maximal gait speed

  9. Changes in Functional performance: Stair climbing performance

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

    Changes in time required to climb a specific staircase

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

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

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

  11. Changes in Body composition and anthropometrics: Body mass

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

    Changes in body mass

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

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

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

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

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

    Changes in total fat mass assessed by DXA

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

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

    Changes in bone mineral density assessed by DXA

  15. Changes in Body composition and anthropometrics: Waist circumference

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

    Changes in waist circumference

  16. Changes in Body composition and anthropometrics: Hip circumference

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

    Changes in Hip circumference

  17. Changes in Systolic Blood pressure

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

    Changes in resting systolic blood pressure

  18. Changes in Diastolic Blood pressure

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

    Changes in resting diastolic blood pressure

  19. Changes in Heart rate

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

    Changes in resting heart rate

  20. Changes in Blood biochemistry: leukocyte differential counts

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

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

  21. Changes in Blood biochemistry: C-reactive protein

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

    Changes in resting C-reactive protein levels in blood

  22. Changes in Blood biochemistry: Insulin

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

    Changes in resting insulin blood levels

  23. Changes in Blood biochemistry: Glucose

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

    Changes in resting glucose blood levels

  24. Changes in Blood biochemistry: Triglycerides

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

    Changes in resting triglycerides blood levels

  25. Changes in Blood biochemistry: LDL-Cholesterol

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

    Changes in resting LDL-cholesterol blood levels

  26. Changes in Blood biochemistry: HDL-Cholesterol

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

    Changes in resting HDL-cholesterol blood levels

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

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

    Changes in resting Interleukin-6 blood levels

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

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

    Changes in resting Interleukin-1 blood levels

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

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

    Changes in resting Interleukin-7 blood levels

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

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

    Changes in resting Interleukin-8 blood levels

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

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

    Changes in resting Interleukin-15 blood levels

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

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

    Changes in resting Interleukin-1β blood levels

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

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

    Changes in resting Interleukin-10 blood levels

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

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

    Changes in resting TNFalpha blood levels

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

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

    Changes in resting IFN-gamma blood levels

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

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

    Changes in resting NK cells

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

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

    Changes in resting CD4 T cells

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

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

    Changes in resting CD8 T cells

  39. Changes in Immune cells in blood: B cells

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

    Changes in resting B cells

  40. Changes in Osteonectin

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

    Changes in resting osteonectin blood levels

  41. Changes in Patient-reported symptomatic adverse events

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

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

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

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

    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)

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

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

    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)

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

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

    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)

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

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

    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)

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

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

    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)

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

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

    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)

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

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

    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)

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

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

    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)

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

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

    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)

  51. Changes in Depression

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

    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)

  52. Changes in Anxiety

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

    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)

  53. Changes in Physical activity: Walking

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

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

  54. Changes in Physical activity: Moderate intensity physical activity

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

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

  55. Changes in Physical activity: Vigorous intensity physical activity

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

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

  56. Changes in Physical activity: Total intensity physical activity

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

    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)

  57. Changes in Physical activity: sitting time

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

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

  58. Changes in Circulating tumor DNA (ctDNA)

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

    Changes in ctDNA in blood

  59. Changes in DNA methylation

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

    Changes in DNA methylation derived from blood

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

    Time frame: From date of planned initiation to end of adjuvant chemotherapy

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

  61. Postoperative hospital admissions

    Time frame: From discharge to 12 months after exercise training initiation

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

  62. Postoperative complications

    Time frame: From discharge to 30 days after discharge

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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Post-Operative Exercise Training in Patients With Metastatic Colorectal Cancer

Acronym: POET-mCRC

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Oct 13, 2022
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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