Metastatic Colorectal Cancer (mCRC)REACHNCT06938971
Randomized Controlled Trial of the Effects of Combined Resistance and AerobiC Exercise on Health-related Quality of Life in Patients Undergoing First-line Chemotherapy for Metastatic Colorectal Cancer (REACH)
A study testing Exercise training in people with Metastatic Colorectal Cancer (mCRC), run by Copenhagen University Hospital, Rigshospitalet at 4 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer (mCRC)
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesDenmark
- Study dates
- 16 May 2025to 1 May 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years of age) schduled to undergo first-line chemotherapy for the treatment of metastatic colorectal cancer.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark4 sites, 4 recruiting
- Recruiting
Centre for Physical Activity Research, Copenhagen Univerisity Hospital - Rigshospitalet
Copenhagen, 2100
Casper Simonsen, PhD, +45 35 45 76 41, casper.simonsen@regionh.dk
- Recruiting
Herlev and Gentofte Hospital
Herlev, 2730
Louise Lang Lehrskov, 0045 38689394, louise.lang.lehrskov.01@regionh.dk
- Recruiting
North Zealand University Hospital, Hillerød
Hillerød, 3400
Louise Lang Lehrskov, louise.lang.lehrskov.01@regionh.dk
- Recruiting
Zealand University Hospital, Roskilde
Roskilde, 4000
Louise Lang Lehrskov, 35457641, louise.lang.lehrskov.01@regionh.dk
About this study
Official title: Effects of Exercise Training on Health-related Quality of Life in Patients With Unresectable Metastatic Colorectal Cancer: A Multi-center Randomized Controlled Trial
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.
- Conditions
- Metastatic Colorectal Cancer (mCRC)
- Being tested
- Exercise training
- Keywords
- Exercise, Physical activity, Metastatic colorectal cancer, Colorectal cancer, Endurance training, Oncology, Chemotherapy
- Medical subject headings
- Colorectal Neoplasms, Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 3 weeks from randomization until post-intervention (18 weeks), withdrawal of consent to participate, or death (whichever occurs first)
Secondary outcomes (28)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From randomization to 20 weeks after randomization
Unscheduled hospitalizations
Unscheduled hospitalizations.
Measured: From randomization to 20 weeks after randomization
Dose delays of chemotherapy
A chemotherapy dose delay is a delay of the planned administation of chemotherapy.
Measured: From randomization to 20 weeks after randomization
Dose reductions of chemotherapy
A chemotherapy dose reduction is a decrease of the planned dose of chemotherapy.
Measured: From randomization to 20 weeks after randomization
Discontinuation of chemotherapy
Discontinuation of chemotherapy is a premature discontinuation of the planned chemotherapy.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Randomization, 18 weeks after randomization
Body mass index
Between-group difference in changes from randomizationto 18 weeks after randomization.
Measured: Randomization, 18 weeks after randomization
Resting heart rate
Between-group difference in changes from randomization to 18 weeks after randomization. Reported as beats/min.
Measured: Randomization, 18 weeks after randomization
Systolic blood pressure
Between-group difference in changes from randomizationto 18 weeks after randomization. Reported as mmHg.
Measured: Randomization, 18 weeks after randomization
Diatolic blood pressure
Between-group difference in changes from randomizationto 18 weeks after randomization. Reported as mmHg.
Measured: Randomization, 18 weeks after randomization
5-year overall survival
Overall survival, defined as the time from randomization to death.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: From randomization to 20 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start16 May 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Cancer (mCRC)Studies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Casper Simonsen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938971
- Sponsor's protocol ID
- Exercise mCRC
- Acronym
- REACH
- Status last verified
- May 2026
- First submitted
- 31 Mar 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided