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)

Rigshospitalet

Status: Enrolling

Conditions: Metastatic Colorectal Cancer (mCRC)

Treatments: Other: Exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT06938971

Exercise mCRC

Details and patient eligibility

About

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 unresectable mCRC.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

• Adults (≥18 years of age) schduled to undergo chemotherapy for the treatment of unresectable 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Control

No Intervention group

Description:

Participants allocated to the control group will receive standard care. No restrictions regarding physical activity will be imposed.

Exercise training

Experimental group

Description:

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.

Treatment:

Other: Exercise training