Recruiting 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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise training.
- Who it may be relevant to
- Registry conditions: Metastatic Colorectal Cancer (mCRC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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 mCRC undergoing first-line chemotherapy.
Interventions
- Other 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.
Primary outcome measures
- Health-related quality of life [Time frame: Every 3 weeks from randomization until post-intervention (18 weeks), withdrawal of consent to participate, or death (whichever occurs first)]
Secondary outcome measures (12)
- Health-related quality of life [Time frame: 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.]
- Colorectal cancer-specific symptoms [Time frame: 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.]
- Cancer related fatigue [Time frame: 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.]
- Patient-reported symptomatic adverse events [Time frame: 7 days after every second cycle of treatment, starting from the second cycle. Each cycle is 2-3 weeks, depending on the regimen.]
- Serious adverse events [Time frame: From randomization to 20 weeks after randomization]
- Unscheduled hospitalizations [Time frame: From randomization to 20 weeks after randomization]
- Dose delays of chemotherapy [Time frame: From randomization to 20 weeks after randomization]
- Dose reductions of chemotherapy [Time frame: From randomization to 20 weeks after randomization]
- Discontinuation of chemotherapy [Time frame: From randomization to 20 weeks after randomization]
- Estimated maximal oxygen uptake [Time frame: Randomization, 18 weeks after randomization]
- Estimated maximal oxygen uptake [Time frame: Randomization, 18 weeks after randomization]
- Hand-grip strength [Time frame: Randomization, 18 weeks after randomization]
Eligibility criteria
Inclusion criteria
\- Adults (≥18 years of age) schduled to undergo first-line chemotherapy for the treatment of 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Denmark · 4 centers
- Centre for Physical Activity Research, Copenhagen Univerisity Hospital - Rigshospitalet — Copenhagen
- Herlev and Gentofte Hospital — Herlev
- North Zealand University Hospital, Hillerød — Hillerød
- Zealand University Hospital, Roskilde — Roskilde
Identifiers
NCT: NCT06938971 · Exercise mCRC