Metastatic Colorectal Cancer (mCRC)
Conditions
Keywords
Exercise, Physical activity, Metastatic colorectal cancer, Colorectal cancer, Endurance training, Oncology, Chemotherapy
Brief summary
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.
Interventions
OTHERExercise training
Participants allocated to the exercise intervention group will receive standard care plus an exercise intervention. The exercise intervention will consist moderate-to-high intensity supervised and unsupervised home-based exercise training (bicyling, walking, or running) 5 times/week for 18 weeks.
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Adults (≥18 years of age) schduled to undergo first-line chemotherapy for the treatment of metastatic colorectal cancer.
Exclusion criteria
: * 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 \> 2. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to progression, defined as the time from randomization to disease progression | From randomization to 5 years after randomization | Time to progression, defined as the time from randomization to disease progression |
| Time to treatment failure | From randomization to 5 years after randomization | Time to treatment failure, defined as the time from initiation of treatment to early discontinuation. |
| Proportion of participants undergoing intended curative surgery from randomization to post-intervention. | From randomization to 20 weeks after randomization | Proportion of participants undergoing intended curative surgery. |
| Diatolic blood pressure | Randomization, 18 weeks after randomization | Between-group difference in changes from randomizationto 18 weeks after randomization. Reported as mmHg. |
| 5-year overall survival | From randomization to 5 years after randomization | Overall survival, defined as the time from randomization to death. |
| 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. | The difference in means of the average health-related quality of life score (global score and score for each subcomponent) 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. |
| 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. | The difference in means of the average colorectal cancer-specific symptoms inter-vention versus control, regardless of intervention compliance; disease pro-gression; cancer treatment discontinuation or dose-modifications; changes in initially scheduled cancer treatment; and engagement in alternative can-cer 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 CR 29. Scores range from 0 to 100. |
| 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. | Between-group difference in changes in cancer related fatigue from randomization to 6, 12, 18, 36, 52, 104, and 156 weeks after randomization. Cancer related fatigue will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core FA12. Scores range from 0 to 100. |
| 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. | Patient-reported symptomatic adverse events will be assessed, using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). A total of 42 symptomatic adverse events have been preselected based on high expected prevalence in patients with colorectal cancer. |
| Serious adverse events | From randomization to 20 weeks after randomization | Serious adverse events. |
| Unscheduled hospitalizations | From randomization to 20 weeks after randomization | Unscheduled hospitalizations. |
| Dose delays of chemotherapy | From randomization to 20 weeks after randomization | A chemotherapy dose delay is a delay of the planned administation of chemotherapy. |
| Dose reductions of chemotherapy | From randomization to 20 weeks after randomization | A chemotherapy dose reduction is a decrease of the planned dose of chemotherapy. |
| Discontinuation of chemotherapy | From randomization to 20 weeks after randomization | Discontinuation of chemotherapy is a premature discontinuation of the planned chemotherapy. |
| Estimated maximal oxygen uptake | Randomization, 18 weeks after randomization | Between-group difference in changes from randomization to 18 weeks after randomization. Maximal oxygen uptake (mL/kg/min) will be estimated from ratings of perceived exertion obtained during submaximal exercise. |
| Hand-grip strength | Randomization, 18 weeks after randomization | Between-group difference in changes from randomization to 18 weeks after randomization. Handgrip strength (kg) of the dominant hand will be measured using a dynamometer |
| Balance | Randomization, 18 weeks after randomization | Between-group difference in changes from randomizationto 18 weeks after randomization. Standing balance will be assessed using side-by-side stands, semi-tandem stands, and tandem stands. The time until the participants move their feet or grasp for support will be measured. The test is terminated after 10 seconds. Balance will be scored in accordance with the standardized scoring guidelines of the Short Physical Performance Battery (SPPB). |
| Habitual 4 m Gait Speed | Randomization, 18 weeks after randomization | Between-group difference in changes from randomization to 18 weeks after randomization. Habitual 4 m gait speed will be measured on a 4 m straight, flat walking course and scored in accordance with the standardized scoring guidelines of the Short Physical Performance Battery (SPPB). |
| Chair Rising Capacity | Randomization, 18 weeks after randomization | Between-group difference in changes from randomizationto 18 weeks after randomization. Chair rising capacity will be assessed using a sit-to-stand test. The time taken to perform five stands will be measured and scored in accordance with the standardized scoring guidelines of the Short Physical Performance Battery (SPPB). |
| Short Physical Performance Battery (SPPB) total score | Randomization, 18 weeks after randomization | Between-group difference in changes from randomization to 18 weeks after randomization. The Short Physical Performance Battery (SPPB) total score will be calculatedin accordance with the standardized scoring guidelines of the SPPB. |
| Lean mass | Randomization, 18 weeks after randomization | Between-group difference in changes from randomization to 18 weeks after randomization. Whole-body lean mass (kg) will be measured using bioelectrical impedance analysis. |
| Fat mass | Randomization, 18 weeks after randomization | Between-group difference in changes from randomization to 18 weeks after randomization. Whole-body fat mass (kg) will be measured using bioelectrical impedance analysis. |
| Body mass | Randomization, 18 weeks after randomization | Between-group difference in changes from randomizationto 18 weeks after randomization. Body mass (kg) will be measured using an electronic scale. |
| Body mass index | Randomization, 18 weeks after randomization | Between-group difference in changes from randomizationto 18 weeks after randomization. |
| Resting heart rate | Randomization, 18 weeks after randomization | Between-group difference in changes from randomization to 18 weeks after randomization. Reported as beats/min. |
| 5-year progression-free survival, defined as the time from randomization to disease progression or death | From randomization to 5 years after randomization | 5-year progression-free survival, defined as the time from randomization to disease progression or death. |
| Systolic blood pressure | Randomization, 18 weeks after randomization | Between-group difference in changes from randomizationto 18 weeks after randomization. Reported as mmHg. |
Countries
Denmark
Contacts
CONTACTCasper Simonsen, Phd
Outcome results
None listed