Clinical trial NCT05579340: Postoperative Exercise Training and Colorectal Cancer Liver Metastasis
Official title: Post-Operative Exercise Training in Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer Metastatic to Liver
Cancer Colorectal
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in peak oxygen consumption (VO2peak)
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
Secondary outcomes:
measure: 3-years recurrence-free survival
timeFrame: Randomization to 3 years after randomization
measure: 3-years overall survival
timeFrame: Randomization to 3 years after randomization
measure: Changes in Aerobic Capacity: Ventilatory threshold
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Aerobic Capacity: Peak power output
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Muscle strength: Hand grip strength
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Muscle strength: Leg press maximal muscle strength
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Functional performance: Habitual gait speed
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Functional performance: Maximal gait speed
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Functional performance: Stair climbing performance
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Functional performance: 30 seconds Sit-to-stand
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Body composition and anthropometrics: Body mass
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Body composition and anthropometrics: Total lean mass
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Body composition and anthropometrics: Total fat mass
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Body composition and anthropometrics: Bone mineral density
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Body composition and anthropometrics: Waist circumference
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Body composition and anthropometrics: Hip circumference
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Systolic Blood pressure
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Diastolic Blood pressure
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Heart rate
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Blood biochemistry: leukocyte differential counts
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Blood biochemistry: C-reactive protein
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Blood biochemistry: Insulin
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Blood biochemistry: Glucose
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Blood biochemistry: Triglycerides
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Blood biochemistry: LDL-Cholesterol
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Blood biochemistry: HDL-Cholesterol
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Cytokine levels in blood: Interleukin-6
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Cytokine levels in blood: Interleukin-1
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Cytokine levels in blood: Interleukin-7
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Cytokine levels in blood: Interleukin-8
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Cytokine levels in blood: Interleukin-15
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Cytokine levels in blood: Interleukin-1β
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Cytokine levels in blood: Interleukin-10
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Cytokine levels in blood: Tumor-necrosis-factor alpha (TNFalpha)
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Cytokine levels in blood: Interferon gamma (IFN-gamma)
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Immune cells in blood: Natural killer (NK) cells
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Immune cells in blood: CD4 T cells
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Immune cells in blood: CD8 T cells
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Immune cells in blood: B cells
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Osteonectin
timeFrame: Baseline, 3-, 6-, 9- and 12 months after exercise training initiation
measure: Changes in Patient-reported symptomatic adverse events
timeFrame: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation
measure: Changes in Health-related quality of life: Physical well-being
timeFrame: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation
measure: Changes in Health-related quality of life: Social well-being
timeFrame: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation
measure: Changes in Health-related quality of life: Emotional well-being
timeFrame: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation
measure: Changes in Health-related quality of life: Functional well-being
timeFrame: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation
measure: Changes in Health-related quality of life: General
timeFrame: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation
measure: Changes in Health-related quality of life: Colorectal cancer specific
timeFrame: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation
measure: Changes in Health-related quality of life: total score
timeFrame: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation
measure: Changes in Health-related quality of life: Trial outcome index
timeFrame: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation
measure: Changes in Health-related quality of life: Fatigue
timeFrame: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation
measure: Changes in Depression
timeFrame: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation
measure: Changes in Anxiety
timeFrame: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation
measure: Changes in Physical activity: Walking
timeFrame: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation
measure: Changes in Physical activity: Moderate intensity physical activity
timeFrame: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation
measure: Changes in Physical activity: Vigorous intensity physical activity
timeFrame: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation
measure: Changes in Physical activity: Total intensity physical activity
timeFrame: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation
measure: Changes in Physical activity: sitting time
timeFrame: Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation
measure: Changes in Circulating tumor DNA (ctDNA)
timeFrame: Baseline, 6-, and 12 months after exercise training initiation
measure: Changes in DNA methylation
timeFrame: Baseline, 6-, and 12 months after exercise training initiation
measure: Changes in treatment tolerance: Relative dose intensity (RDI) of adjuvant chemotherapy
timeFrame: From date of planned initiation to end of adjuvant chemotherapy
measure: Postoperative hospital admissions
timeFrame: From discharge to 12 months after exercise training initiation
measure: Postoperative complications
timeFrame: From discharge to 30 days after discharge
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet (CFAS)
Study officials:
affiliation: Group Leader
name: Casper Simonsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: