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)
REACH
Effects of Exercise Training on Health-related Quality of Life in Patients With Unresectable Metastatic Colorectal Cancer: A Multi-center Randomized Controlled Trial
1 other identifier
interventional
150
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2025
CompletedFirst Posted
Study publicly available on registry
April 22, 2025
CompletedStudy Start
First participant enrolled
May 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2030
May 13, 2026
May 1, 2026
2 years
March 31, 2025
May 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (28)
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.
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.
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.
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.
Serious adverse events
From randomization to 20 weeks after randomization
- +23 more secondary outcomes
Study Arms (2)
Control
NO INTERVENTIONParticipants allocated to the control group will receive standard care. No restrictions regarding physical activity will be imposed.
Exercise training
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- \- Adults (≥18 years of age) schduled to undergo first-line chemotherapy for the treatment of metastatic colorectal cancer.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Centre for Physical Activity Research, Copenhagen Univerisity Hospital - Rigshospitalet
Copenhagen, 2100, Denmark
Herlev and Gentofte Hospital
Herlev, 2730, Denmark
North Zealand University Hospital, Hillerød
Hillerød, 3400, Denmark
Zealand University Hospital, Roskilde
Roskilde, 4000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Group Leader
Study Record Dates
First Submitted
March 31, 2025
First Posted
April 22, 2025
Study Start
May 16, 2025
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2030
Last Updated
May 13, 2026
Record last verified: 2026-05