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Clinical Trials in Denmark / NCT06938971
Recruiting Not applicable

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)

NCT06938971 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen University Hospital, Rigshospitalet
Phase
Not applicable
Started
2025-05-16
Last updated
2026-05-13

Condition(s) studied

Metastatic Colorectal Cancer (mCRC)

Investigational drug(s) / intervention(s)

Exercise training

Exercise training: 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria: \- Adults (≥18 years of age) schduled to undergo first-line chemotherapy for the treatment of metastatic colorectal cancer. Exclusion criteria : * 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.

Primary outcome measure(s)

  • 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.

Trial sites (4)

FacilityCityRegionStatus
Centre for Physical Activity Research, Copenhagen Univerisity Hospital - Rigshospitalet Copenhagen Denmark Recruiting
Herlev and Gentofte Hospital Herlev Denmark Recruiting
North Zealand University Hospital, Hillerød Hillerød Denmark Recruiting
Zealand University Hospital, Roskilde Roskilde Denmark Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06938971 on ClinicalTrials.gov ↗ ← All trials in Denmark