Postoperative Exercise Training and Colorectal Cancer Liver Metastasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-30

Study Completion Date

2025-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer Metastatic to Liver Cancer Colorectal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Ex1

Low exercise volume (150 min/week)

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

6 months of combined aerobic and resistance exercise

Ex2

High exercise volume (300 min/week)

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

6 months of combined aerobic and resistance exercise

Interventions

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Exercise

6 months of combined aerobic and resistance exercise

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No