Experiences of patients with metastatic colorectal cancer participating in a supervised exercise intervention during chemotherapy.
Calvin G Brouwer, Marieke R Ten Tusscher, Bente M de Roos...
https://pubmed.ncbi.nlm.nih.gov/39779537Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID04754672
Aerobic Fitness or Muscle Mass Training to Improve Colorectal Cancer Outcome (AMICO) The Effects of Exercise on Chemotherapy Dose Modification and Progression Free Survival in Patients With Metastatic Colorectal Cancer
Led by Radboud University Medical Center · Updated on 2023-11-18
228
Participants Needed
13
Research Sites
39 weeks
Total Duration
On this page
Sponsors
R
Radboud University Medical Center
Lead Sponsor
U
UMC Utrecht
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how exercise might affect treatment outcomes for patients with metastatic colorectal cancer receiving chemotherapy. The study focuses on whether exercise can prevent changes to chemotherapy doses caused by toxicity, improve immune function, and enhance progression-free survival. It also seeks to identify the best type and amount of exercise for these benefits. This is a randomized, multi-arm trial using a Bayesian adaptive design to efficiently compare different exercise programs while minimizing patient exposure to less effective options. Participants are randomly assigned to one of three groups: a resistance and continuous aerobic exercise group, an aerobic interval and continuous aerobic exercise group, or a usual care group. Those in the exercise groups engage in supervised moderate-to-high intensity sessions twice a week, plus a third session at home. The exercise includes activities like walking, cycling, and resistance exercises targeting large muscle groups. The usual care group receives standard treatment with exercise guidelines provided. The study uses several interim analyses to potentially stop less effective exercise arms early. During the study, participants undergo regular assessments including chemotherapy dose modifications, progression-free survival, immune cell function, hospitalization, treatment-related toxicities, fitness, muscle strength and mass, quality of life, fatigue, resilience, empowerment, and physical activity levels. These measures are taken from baseline through multiple chemotherapy cycles over several months, with outcomes monitored for up to two years. The study aims to better understand how exercise affects treatment effectiveness and patient well-being in metastatic colorectal cancer.
CONDITIONS
Brief Title
Aerobic Fitness or Muscle Mass Training to Improve Colorectal Cancer Outcome
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with metastatic colorectal cancer and indicated for palliative chemotherapy
- Scheduled for first-line doublet or triplet chemotherapy according to national guidelines
- Able and willing to give written informed consent
You will not qualify if you...
- Life expectancy less than 6 months
- Unable to perform basic activities of daily living such as walking or biking
- Presence of cognitive disorders or severe emotional instability (e.g., schizophrenia, Alzheimer disease, alcohol addiction)
- Presence of disabling co-morbidities that might hamper physical exercise (e.g., advanced heart failure, severe COPD, orthopedic conditions, neurological disorders)
- Insufficient mastery of the Dutch language
- Serious cardiovascular or cardiopulmonary conditions that make exercise unsafe as judged by the treating physician
- Already participating in structured vigorous aerobic and/or resistance exercise two or more times per week comparable to the study intervention
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - Up to 6 to 8 treatment cycles (each cycle 2 to 3 weeks)
Participants engage in exercise programs alongside their chemotherapy treatment to evaluate effects on chemotherapy dose modifications, immune function, and progression-free survival.
Two 60-minute supervised exercise sessions per week plus one additional home session weekly
Follow-up
Duration - Up to 2 years
Participants are monitored for progression-free survival and long-term outcomes after completion of the exercise and chemotherapy treatment phase.
Periodic follow-up visits as per study schedule
Trial Site Locations
Total: 13 locations
1
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands, 5223 GZ
Actively Recruiting
2
Flevoziekenhuis
Almere Stad, Netherlands, 1315 RA
Actively Recruiting
3
Meander Medisch Centrum
Amersfoort, Netherlands, 3813TZ
Actively Recruiting
4
Ziekenhuis Amstelland
Amstelveen, Netherlands, 1186AM
Actively Recruiting
5
Amsterdam UMC
Amsterdam, Netherlands, 1007MB
Actively Recruiting
6
Netherlands Cancer Institute
Amsterdam, Netherlands
Actively Recruiting
7
Rijnstate Ziekenhuis
Arnhem, Netherlands, 6815 AD
Actively Recruiting
8
Ziekenhuis Amphia
Breda, Netherlands, 4818CK
Actively Recruiting
9
Catharina Ziekenhuis
Eindhoven, Netherlands, 5623 EJ
Actively Recruiting
10
Spaarne Gasthuis
Hoofddorp, Netherlands, 2134TM
Actively Recruiting
11
Radboudumc
Nijmegen, Netherlands, 6525GA
Actively Recruiting
12
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands, 6532SZ
Actively Recruiting
13
UMCU
Utrecht, Netherlands, 3508GA
Actively Recruiting
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Research Team
L
Laurien M Buffart, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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