Clinical trial NCT06938971: 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)
Official title: Effects of Exercise Training on Health-related Quality of Life in Patients With Unresectable Metastatic Colorectal Cancer: A Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Colorectal Cancer (mCRC)
Keywords: Exercise
Physical activity
Metastatic colorectal cancer
Colorectal cancer
Endurance training
Oncology
Chemotherapy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Health-related quality of life
timeFrame: Every 3 weeks from randomization until post-intervention (18 weeks), withdrawal of consent to participate, or death (whichever occurs first)
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 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.
measure: Colorectal cancer-specific symptoms
timeFrame: 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.
measure: Cancer related fatigue
timeFrame: 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.
measure: Patient-reported symptomatic adverse events
timeFrame: 7 days after every second cycle of treatment, starting from the second cycle. Each cycle is 2-3 weeks, depending on the regimen.
measure: Serious adverse events
timeFrame: From randomization to 20 weeks after randomization
measure: Unscheduled hospitalizations
timeFrame: From randomization to 20 weeks after randomization
measure: Dose delays of chemotherapy
timeFrame: From randomization to 20 weeks after randomization
measure: Dose reductions of chemotherapy
timeFrame: From randomization to 20 weeks after randomization
measure: Discontinuation of chemotherapy
timeFrame: From randomization to 20 weeks after randomization
measure: Estimated maximal oxygen uptake
timeFrame: Randomization, 18 weeks after randomization
measure: Estimated maximal oxygen uptake
timeFrame: Randomization, 18 weeks after randomization
measure: Hand-grip strength
timeFrame: Randomization, 18 weeks after randomization
measure: Balance
timeFrame: Randomization, 18 weeks after randomization
measure: Habitual 4 m Gait Speed
timeFrame: Randomization, 18 weeks after randomization
measure: Chair Rising Capacity
timeFrame: Randomization, 18 weeks after randomization
measure: Short Physical Performance Battery (SPPB) total score
timeFrame: Randomization, 18 weeks after randomization
measure: Lean mass
timeFrame: Randomization, 18 weeks after randomization
measure: Fat mass
timeFrame: Randomization, 18 weeks after randomization
measure: Body mass
timeFrame: Randomization, 18 weeks after randomization
measure: Body mass index
timeFrame: Randomization, 18 weeks after randomization
measure: Resting heart rate
timeFrame: Randomization, 18 weeks after randomization
measure: Systolic blood pressure
timeFrame: Randomization, 18 weeks after randomization
measure: Diatolic blood pressure
timeFrame: Randomization, 18 weeks after randomization
measure: 3-year overall survival
timeFrame: From randomization to 3 years after randomization
measure: 3-year progression-free survival, defined as the time from randomization to disease progression or death
timeFrame: From randomization to 3 years after randomization
measure: Time to progression, defined as the time from randomization to disease progression
timeFrame: From randomization to 3 years after randomization
measure: Time to treatment failure
timeFrame: From randomization to 3 years after randomization
measure: Proportion of participants undergoing intended curative surgery from randomization to post-intervention.
timeFrame: From randomization to 20 weeks after randomization
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Centre for Physical Activity Research, Copenhagen Univerisity Hospital - Rigshospitalet
city: Herlev
country: Denmark
facility: Herlev and Gentofte Hospital
city: Hillerød
country: Denmark
facility: North Zealand University Hospital, Hillerød
city: Roskilde
country: Denmark
facility: Zealand University Hospital, Roskilde
Study officials:
References: