Effects of Exercise Training on Health-related Quality of Life in Patients With Unresectable Metastatic Colorectal Cancer: A Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 7
- 主要终点
- Health-related quality of life
研究概览
简要总结
The primary objective of this trial is to compare the effects of 18 weeks structured exercise training versus on control on healt-related quality of life in patients with mCRC undergoing first-line chemotherapy.
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
- •- Adults (≥18 years of age) schduled to undergo first-line chemotherapy for the treatment of metastatic colorectal cancer.
排除标准
- •Pregnancy.
- •A life expectancy of < 6 months.
- •Absolute contraindications to maximal exercise, as per the recommendations by the Danish Society of Cardiology.
- •ECOG (Eastern Cooperative Oncology Group) performance status >
- •Inability to understand the Danish or English language.
- •Engagement in structured moderate-to-high aerobic exercise training for >30 min >1 times/week for the past 3 months at the time of inclusion.
研究组 & 干预措施
Control
Participants allocated to the control group will receive standard care. No restrictions regarding physical activity will be imposed.
Exercise training
Participants allocated to the exercise intervention group will receive standard care plus an exercise intervention. The exercise intervention will of consist moderate-to-high intensity supervised and unsupervised home-based exercise training (bicyling, walking, or running) 5 times/week for 18 weeks. After the initial 18-week intervention period, participants will be given the option to continue the intervention until week 162.
干预措施: Exercise training (Other)
结局指标
主要结局
Health-related quality of life
时间窗: Every 3 weeks from randomization until post-intervention (18 weeks), withdrawal of consent to participate, or death (whichever occurs first)
The difference in means of the average global health-related quality of life score in intervention versus control, regardless of intervention compliance; disease progression; cancer treatment discontinuation or dose-modifications; changes in initially scheduled cancer treatment; and engagement in alternative cancer care, in physical activity, structured exercise training, or municipality-based cancer rehabilitation. Health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Scores range from 0 to 100, with higher scores indicating better health-related quality of life.
次要结局
- Unscheduled hospitalizations(From randomization to 20 weeks after randomization)
- Estimated maximal oxygen uptake(Randomization, 18 weeks after randomization)
- Hand-grip strength(Randomization, 18 weeks after randomization)
- Short Physical Performance Battery (SPPB) total score(Randomization, 18 weeks after randomization)
- Lean mass(Randomization, 18 weeks after randomization)
- Fat mass(Randomization, 18 weeks after randomization)
- Body mass(Randomization, 18 weeks after randomization)
- Body mass index(Randomization, 18 weeks after randomization)
- Resting heart rate(Randomization, 18 weeks after randomization)
- Systolic blood pressure(Randomization, 18 weeks after randomization)
- Diatolic blood pressure(Randomization, 18 weeks after randomization)
- Proportion of participants undergoing intended curative surgery from randomization to post-intervention.(From randomization to 20 weeks after randomization)
- Dose delays of chemotherapy(From randomization to 20 weeks after randomization)
- Dose reductions of chemotherapy(From randomization to 20 weeks after randomization)
- Discontinuation of chemotherapy(From randomization to 20 weeks after randomization)
- 5-year overall survival(From randomization to 5 years after randomization)
- 5-year progression-free survival, defined as the time from randomization to disease progression or death(From randomization to 5 years after randomization)
- Time to progression, defined as the time from randomization to disease progression(From randomization to 5 years after randomization)
- Time to treatment failure(From randomization to 5 years after randomization)
- Colorectal cancer-specific symptoms(Randomization and 3, 6, 9, 12, 15, and 18 weeks after randomization or until withdrawal of consent to participate, or death (whichever occurs first). Followed-up at 36, 52, 104, and 156 weeks after randomization.)
- Serious adverse events(From randomization to 20 weeks after randomization)
- Health-related quality of life(Randomization and 3, 6, 9, 12, 15, and 18 weeks after randomization or until withdrawal of consent to participate, or death (whichever occurs first). Followed-up at 36, 52, 104, and 156 weeks after randomization.)
- Cancer related fatigue(Randomization and 3, 6, 9, 12, 15, and 18 weeks after randomization or until withdrawal of consent to participate, or death (whichever occurs first). Followed-up at 36, 52, 104, and 156 weeks after randomization.)
- Patient-reported symptomatic adverse events(7 days after every second cycle of treatment, starting from the second cycle. Each cycle is 2-3 weeks, depending on the regimen.)
- Balance(Randomization, 18 weeks after randomization)
- Habitual 4 m Gait Speed(Randomization, 18 weeks after randomization)
- Chair Rising Capacity(Randomization, 18 weeks after randomization)
研究者
Casper Simonsen
Group Leader
Rigshospitalet, Denmark