Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06938971

Effects of Exercise Training on Health-related Quality of Life in Patients With Unresectable Metastatic Colorectal Cancer: A Multi-center Randomized Controlled Trial

Led by Rigshospitalet, Denmark · Updated on 2026-05-13

150

Participants Needed

4

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of 18 weeks of structured exercise training compared to standard care on the health-related quality of life in adults with metastatic colorectal cancer receiving first-line chemotherapy. The study aims to understand how exercise may influence quality of life during cancer treatment and is sponsored by Rigshospitalet, Denmark. Participants are randomly assigned to one of two groups. One group receives standard care without exercise restrictions. The other group receives standard care plus a combined resistance and aerobic exercise program involving moderate-to-high intensity supervised and unsupervised home-based activities such as bicycling, walking, or running, performed five times per week for 18 weeks. After this initial period, participants can choose to continue the exercise program until week 162. During the study, participants' health-related quality of life is assessed every three weeks up to 18 weeks and at longer follow-up intervals up to 156 weeks. Other measurements include cancer symptoms, fatigue, adverse events, physical performance tests, body composition, vital signs, and survival outcomes. Safety monitoring includes reporting hospitalizations, chemotherapy dose changes, and serious adverse events. The total participation may last up to five years, including extended follow-up for long-term outcomes.

CONDITIONS

Brief Title

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)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults (≥18 years of age) scheduled to undergo first-line chemotherapy for the treatment of metastatic colorectal cancer.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 18 weeks

Participants in the exercise group will undergo moderate-to-high intensity supervised and unsupervised home-based exercise training (bicycling, walking, or running) 5 times per week for 18 weeks alongside standard care. Participants in the control group will receive standard care without restrictions on physical activity.

Regular assessments every 3 weeks during the 18 weeks

Follow-up

Duration - Up to 5 years

Participants will be followed up for long-term health-related quality of life and clinical outcomes for up to 5 years after randomization.

Visits at 36, 52, 104, and 156 weeks after randomization

Trial Site Locations

Total: 4 locations

1

Centre for Physical Activity Research, Copenhagen Univerisity Hospital - Rigshospitalet

Copenhagen, Denmark, 2100

Actively Recruiting

2

Herlev and Gentofte Hospital

Herlev, Denmark, 2730

Actively Recruiting

3

North Zealand University Hospital, Hillerød

Hillerød, Denmark, 3400

Actively Recruiting

4

Zealand University Hospital, Roskilde

Roskilde, Denmark, 4000

Actively Recruiting

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Research Team

C

Casper Simonsen, Phd

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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