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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Participants allocated to the control group will receive standard care. No restrictions regarding physical activity will be imposed. | |
| Exercise training | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise training | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Health-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. | Every 3 weeks from randomization until post-intervention (18 weeks), withdrawal of consent to participate, or death (whichever occurs first) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
- Adults (≥18 years of age) schduled to undergo first-line chemotherapy for the treatment of metastatic colorectal cancer.
Exclusion criteria :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Casper Simonsen, Phd | Contact | +45 35 45 76 41 | casper.simonsen@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Physical Activity Research, Copenhagen Univerisity Hospital - Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
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| 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. | 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. | 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. | 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. | From randomization to 20 weeks after randomization |
| Unscheduled hospitalizations | Unscheduled hospitalizations. | From randomization to 20 weeks after randomization |
| Dose delays of chemotherapy | A chemotherapy dose delay is a delay of the planned administation of chemotherapy. | From randomization to 20 weeks after randomization |
| Dose reductions of chemotherapy | A chemotherapy dose reduction is a decrease of the planned dose of chemotherapy. | From randomization to 20 weeks after randomization |
| Discontinuation of chemotherapy | Discontinuation of chemotherapy is a premature discontinuation of the planned chemotherapy. | 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. | 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. | 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 | 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). | 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). | 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). | 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. | 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. | 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. | 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. | Randomization, 18 weeks after randomization |
| Body mass index | Between-group difference in changes from randomizationto 18 weeks after randomization. | Randomization, 18 weeks after randomization |
| Resting heart rate | Between-group difference in changes from randomization to 18 weeks after randomization. Reported as beats/min. | Randomization, 18 weeks after randomization |
| Systolic blood pressure | Between-group difference in changes from randomizationto 18 weeks after randomization. Reported as mmHg. | Randomization, 18 weeks after randomization |
| Diatolic blood pressure | Between-group difference in changes from randomizationto 18 weeks after randomization. Reported as mmHg. | Randomization, 18 weeks after randomization |
| 5-year overall survival | Overall survival, defined as the time from randomization to death. | From randomization to 5 years after randomization |
| 5-year progression-free survival, defined as the time from randomization to disease progression or death | 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 | Time to progression, defined as the time from randomization to disease progression | From randomization to 5 years after randomization |
| Time to treatment failure | Time to treatment failure, defined as the time from initiation of treatment to early discontinuation. | From randomization to 5 years after randomization |
| Proportion of participants undergoing intended curative surgery from randomization to post-intervention. | Proportion of participants undergoing intended curative surgery. | From randomization to 20 weeks after randomization |
| Herlev and Gentofte Hospital | Recruiting | Herlev | 2730 | Denmark |
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| North Zealand University Hospital, Hillerød | Recruiting | Hillerød | 3400 | Denmark |
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| Zealand University Hospital, Roskilde | Recruiting | Roskilde | 4000 | Denmark |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009043 | Motor Activity |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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