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)

Not Applicable

Recruiting

• Conditions: Metastatic Colorectal Cancer (mCRC)

• Registration Number: NCT06938971
• Lead Sponsor: Rigshospitalet, Denmark

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 unresectable mCRC.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-31
• Study First Submitted QC: 2025-04-14
• Study First Posted: 2025-04-22
• Study Start: 2025-05-16
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-01
• Primary Completion: 2027-05-01
• Study Completion: 2030-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Lean mass	Randomization, 18 weeks after randomization	Between-group difference in changes from randomization to 18 weeks after randomization. Whole-body lean mass (kg) will be measured using bioelectrical impedance analysis.
Body mass index	Randomization, 18 weeks after randomization	Between-group difference in changes from randomizationto 18 weeks after randomization.
Resting heart rate	Randomization, 18 weeks after randomization	Between-group difference in changes from randomization to 18 weeks after randomization. Reported as beats/min.
Time to progression, defined as the time from randomization to disease progression	From randomization to 3 years after randomization	Time to progression, defined as the time from randomization to disease progression
Time to treatment failure	From randomization to 3 years after randomization	Time to treatment failure, defined as the time from initiation of treatment to early discontinuation.
Dose reductions of chemotherapy	From randomization to 20 weeks after randomization	A chemotherapy dose reduction is a decrease of the planned dose of chemotherapy.
Discontinuation of chemotherapy	From randomization to 20 weeks after randomization	Discontinuation of chemotherapy is a premature discontinuation of the planned chemotherapy.
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.	The difference in means of the average colorectal cancer-specific symptoms inter-vention versus control, regardless of intervention compliance; disease pro-gression; cancer treatment discontinuation or dose-modifications; changes in initially scheduled cancer treatment; and engagement in alternative can-cer 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 CR 29. Scores range from 0 to 100.
Serious adverse events	From randomization to 20 weeks after randomization	Serious adverse events.
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.	The difference in means of the average health-related quality of life score (global score and score for each subcomponent) 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.
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.	Between-group difference in changes in cancer related fatigue from randomization to 6, 12, 18, 36, 52, 104, and 156 weeks after randomization. Cancer related fatigue will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core FA12. Scores range from 0 to 100.
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.	Patient-reported symptomatic adverse events will be assessed, using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). A total of 42 symptomatic adverse events have been preselected based on high expected prevalence in patients with colorectal cancer.
Balance	Randomization, 18 weeks after randomization	Between-group difference in changes from randomizationto 18 weeks after randomization. Standing balance will be assessed using side-by-side stands, semi-tandem stands, and tandem stands. The time until the participants move their feet or grasp for support will be measured. The test is terminated after 10 seconds. Balance will be scored in accordance with the standardized scoring guidelines of the Short Physical Performance Battery (SPPB).
Habitual 4 m Gait Speed	Randomization, 18 weeks after randomization	Between-group difference in changes from randomization to 18 weeks after randomization. Habitual 4 m gait speed will be measured on a 4 m straight, flat walking course and scored in accordance with the standardized scoring guidelines of the Short Physical Performance Battery (SPPB).
Chair Rising Capacity	Randomization, 18 weeks after randomization	Between-group difference in changes from randomizationto 18 weeks after randomization. Chair rising capacity will be assessed using a sit-to-stand test. The time taken to perform five stands will be measured and scored in accordance with the standardized scoring guidelines of the Short Physical Performance Battery (SPPB).
Hand-grip strength	Randomization, 18 weeks after randomization	Between-group difference in changes from randomization to 18 weeks after randomization. Handgrip strength (kg) of the dominant hand will be measured using a dynamometer
Short Physical Performance Battery (SPPB) total score	Randomization, 18 weeks after randomization	Between-group difference in changes from randomization to 18 weeks after randomization. The Short Physical Performance Battery (SPPB) total score will be calculatedin accordance with the standardized scoring guidelines of the SPPB.
Fat mass	Randomization, 18 weeks after randomization	Between-group difference in changes from randomization to 18 weeks after randomization. Whole-body fat mass (kg) will be measured using bioelectrical impedance analysis.
Body mass	Randomization, 18 weeks after randomization	Between-group difference in changes from randomizationto 18 weeks after randomization. Body mass (kg) will be measured using an electronic scale.
Systolic blood pressure	Randomization, 18 weeks after randomization	Between-group difference in changes from randomizationto 18 weeks after randomization. Reported as mmHg.
Diatolic blood pressure	Randomization, 18 weeks after randomization	Between-group difference in changes from randomizationto 18 weeks after randomization. Reported as mmHg.
3-year overall survival	From randomization to 3 years after randomization	Overall survival, defined as the time from randomization to death.
3-year progression-free survival, defined as the time from randomization to disease progression or death	From randomization to 3 years after randomization	3-year progression-free survival, defined as the time from randomization to disease progression or death.
Proportion of participants undergoing intended curative surgery from randomization to post-intervention.	From randomization to 20 weeks after randomization	Proportion of participants undergoing intended curative surgery.
Unscheduled hospitalizations	From randomization to 20 weeks after randomization	Unscheduled hospitalizations.
Dose delays of chemotherapy	From randomization to 20 weeks after randomization	A chemotherapy dose delay is a delay of the planned administation of chemotherapy.
Estimated maximal oxygen uptake	Randomization, 18 weeks after randomization	Between-group difference in changes from randomization to 18 weeks after randomization. Maximal oxygen uptake (L/min) will be estimated from ratings of perceived exertion obtained during submaximal exercise.

Trial Locations

Locations (4)

Centre for Physical Activity Research, Copenhagen Univerisity Hospital - Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Herlev and Gentofte Hospital; 🇩🇰 Herlev, Denmark

North Zealand University Hospital, Hillerød; 🇩🇰 Hillerød, Denmark

Zealand University Hospital, Roskilde; 🇩🇰 Roskilde, Denmark