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Active Not RecruitingNCT05579340

Postoperative Exercise Training and Colorectal Cancer Liver Metastasis

Post-Operative Exercise Training in Patients With Metastatic Colorectal Cancer

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
66 (estimated)
Sponsor
Rigshospitalet, Denmark · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERExercise6 months of combined aerobic and resistance exercise

Timeline

Start date
2023-04-18
Primary completion
2026-06-01
Completion
2028-06-01
First posted
2022-10-13
Last updated
2026-02-24

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT05579340. Inclusion in this directory is not an endorsement.