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 unresectable mCRC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
150
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.
Centre for Physical Activity Research, Copenhagen Univerisity Hospital - Rigshospitalet
Copenhagen, Denmark
RECRUITINGHerlev and Gentofte Hospital
Herlev, Denmark
RECRUITINGNorth Zealand University Hospital, Hillerød
Hillerød, Denmark
RECRUITINGHealth-related quality of life
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.
Time frame: Every 3 weeks from randomization until post-intervention (18 weeks), withdrawal of consent to participate, or death (whichever occurs first)
Health-related quality of life
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.
Time frame: 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.
Colorectal cancer-specific symptoms
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.
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Zealand University Hospital, Roskilde
Roskilde, Denmark
RECRUITINGTime frame: 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
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.
Time frame: 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
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.
Time frame: 7 days after every second cycle of treatment, starting from the second cycle. Each cycle is 2-3 weeks, depending on the regimen.
Serious adverse events
Serious adverse events.
Time frame: From randomization to 20 weeks after randomization
Unscheduled hospitalizations
Unscheduled hospitalizations.
Time frame: From randomization to 20 weeks after randomization
Dose delays of chemotherapy
A chemotherapy dose delay is a delay of the planned administation of chemotherapy.
Time frame: From randomization to 20 weeks after randomization
Dose reductions of chemotherapy
A chemotherapy dose reduction is a decrease of the planned dose of chemotherapy.
Time frame: From randomization to 20 weeks after randomization
Discontinuation of chemotherapy
Discontinuation of chemotherapy is a premature discontinuation of the planned chemotherapy.
Time frame: From randomization to 20 weeks after randomization
Estimated maximal oxygen uptake
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.
Time frame: Randomization, 18 weeks after randomization
Estimated maximal oxygen uptake
Between-group difference in changes from randomization to 18 weeks after randomization. Maximal oxygen uptake (L/min) will be estimated from ratings of perceived exertion obtained during submaximal exercise.
Time frame: Randomization, 18 weeks after randomization
Hand-grip strength
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
Time frame: Randomization, 18 weeks after randomization
Balance
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).
Time frame: Randomization, 18 weeks after randomization
Habitual 4 m Gait Speed
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).
Time frame: Randomization, 18 weeks after randomization
Chair Rising Capacity
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).
Time frame: Randomization, 18 weeks after randomization
Short Physical Performance Battery (SPPB) total score
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.
Time frame: Randomization, 18 weeks after randomization
Lean mass
Between-group difference in changes from randomization to 18 weeks after randomization. Whole-body lean mass (kg) will be measured using bioelectrical impedance analysis.
Time frame: Randomization, 18 weeks after randomization
Fat mass
Between-group difference in changes from randomization to 18 weeks after randomization. Whole-body fat mass (kg) will be measured using bioelectrical impedance analysis.
Time frame: Randomization, 18 weeks after randomization
Body mass
Between-group difference in changes from randomizationto 18 weeks after randomization. Body mass (kg) will be measured using an electronic scale.
Time frame: Randomization, 18 weeks after randomization
Body mass index
Between-group difference in changes from randomizationto 18 weeks after randomization.
Time frame: Randomization, 18 weeks after randomization
Resting heart rate
Between-group difference in changes from randomization to 18 weeks after randomization. Reported as beats/min.
Time frame: Randomization, 18 weeks after randomization
Systolic blood pressure
Between-group difference in changes from randomizationto 18 weeks after randomization. Reported as mmHg.
Time frame: Randomization, 18 weeks after randomization
Diatolic blood pressure
Between-group difference in changes from randomizationto 18 weeks after randomization. Reported as mmHg.
Time frame: Randomization, 18 weeks after randomization
3-year overall survival
Overall survival, defined as the time from randomization to death.
Time frame: From randomization to 3 years after randomization
3-year progression-free survival, defined as the time from randomization to disease progression or death
3-year progression-free survival, defined as the time from randomization to disease progression or death.
Time frame: From randomization to 3 years after randomization
Time to progression, defined as the time from randomization to disease progression
Time to progression, defined as the time from randomization to disease progression
Time frame: From randomization to 3 years after randomization
Time to treatment failure
Time to treatment failure, defined as the time from initiation of treatment to early discontinuation.
Time frame: From randomization to 3 years after randomization
Proportion of participants undergoing intended curative surgery from randomization to post-intervention.
Proportion of participants undergoing intended curative surgery.
Time frame: From randomization to 20 weeks after randomization