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临床试验/NCT05579340
NCT05579340进行中（未招募）不适用

Post-Operative Exercise Training in Patients With Metastatic Colorectal Cancer

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2023年4月18日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
66
试验地点
1
主要终点
Change in peak oxygen consumption (VO2peak)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

Ex2

Experimental

High exercise volume (300 min/week)

干预措施: Exercise (Other)

Usual care

No Intervention

Ex1

Experimental

Low exercise volume (150 min/week)

干预措施: Exercise (Other)

结局指标

主要结局

Change in peak oxygen consumption (VO2peak)

时间窗: 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

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christina Yfanti

Postdoctoral researcher

Rigshospitalet, Denmark

研究点 (1)

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