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)

NCT ID: NCT06938971

Last Updated: 2025-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-16

Study Completion Date

2030-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Colorectal Cancer (mCRC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Exercise training

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.

Group Type EXPERIMENTAL

Exercise training

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Casper Simonsen

Group Leader

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centre for Physical Activity Research, Copenhagen Univerisity Hospital - Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Herlev and Gentofte Hospital

Herlev, , Denmark

Site Status RECRUITING

North Zealand University Hospital, Hillerød

Hillerød, , Denmark

Site Status RECRUITING

Zealand University Hospital, Roskilde

Roskilde, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Casper Simonsen, Phd

Role: CONTACT

+45 35 45 76 41

Facility Contacts

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Casper Simonsen, PhD

Role: primary

+45 35 45 76 41

Louise Lang Lehrskov

Role: primary

0045 38689394

Louise Lang Lehrskov

Role: primary

Louise Lang Lehrskov

Role: primary

Other Identifiers

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Exercise mCRC

Identifier Type: -

Identifier Source: org_study_id

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