Effects of Exercise Training on Health-related Quality of Life in Patients Undergoing Treatment of Unresectable Metastatic Colorectal Cancer
- Conditions
- Metastatic Colorectal Cancer (mCRC)
- Registration Number
- NCT06938971
- Lead Sponsor
- Rigshospitalet, Denmark
- 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 unresectable mCRC.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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.
Systolic blood pressure Randomization, 18 weeks after randomization Between-group difference in changes from randomizationto 18 weeks after randomization. Reported as mmHg.
Diatolic blood pressure Randomization, 18 weeks after randomization Between-group difference in changes from randomizationto 18 weeks after randomization. Reported as mmHg.
3-year overall survival From randomization to 3 years after randomization Overall survival, defined as the time from randomization to death.
3-year progression-free survival, defined as the time from randomization to disease progression or death From randomization to 3 years after randomization 3-year progression-free survival, defined as the time from randomization to disease progression or death.
Time to progression, defined as the time from randomization to disease progression From randomization to 3 years after randomization Time to progression, defined as the time from randomization to disease progression
Time to treatment failure From randomization to 3 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.
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 (L/min) will be estimated from ratings of perceived exertion obtained during submaximal exercise.
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.
Serious adverse events From randomization to 20 weeks after randomization Serious adverse events.
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.
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.
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).
Trial Locations
- Locations (1)
Centre for Physical Activity Research, Copenhagen Univerisity Hospital - Rigshospitalet
🇩🇰Copenhagen, Denmark