NCT04754672 Aerobic Fitness or Muscle Mass Training to Improve Colorectal Cancer Outcome
| NCT ID | NCT04754672 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Radboud University Medical Center |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 228 participants |
| Start Date | 2021-03-02 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 228 participants in total. It began in 2021-03-02 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Evidence from randomized controlled trials shows that exercise during cancer treatment benefits physical fitness, fatigue and quality of life. Since the effect of exercise on clinical outcome is currently unknown, exercise is not included as integral part of standard cancer care. Moreover, evidence regarding the optimal exercise prescription in terms of type and dose is lacking. To maintain quality of life in patients receiving palliative treatment with chemotherapy, toxicity-induced modifications in the prescribed chemotherapy dose are common. Such modifications - occurring in 40% of patients with metastatic colorectal cancer - may reduce benefit of treatment. The investigators hypothesize that exercise prevents chemotherapy dose modifications by reducing toxicity and enhancing psychological strength. Additionally, based on studies in rodents and preliminary data in patients with cancer, the researchers hypothesize that exercise has beneficial effects on the functionality of the natural killer cells, which play an important role in the innate immune defense against cancer. Both, fewer dose modifications and improved immune function may improve progression-free survival. This study is a three-armed trial comparing resistance exercise, aerobic interval exercise and usual care in patients with metastatic colorectal cancer to select the optimal exercise prescription for preventing chemotherapy dose modifications. The trial will use a Bayesian adaptive multi-arm multi-stage design with several interim analyses after which an ineffective study arm can be dropped early. This novel design makes the trial more efficient and reduces patients' exposure to suboptimal study arms. Evidence regarding the exercise effects on i) clinical outcome, ii) the optimal exercise prescription, and iii) the underlying mechanisms, elucidates the potential of exercise to boost benefit from chemotherapy treatment. This evidence provides leads to improve progression-free survival and quality of life of patients suffering from one of the leading causes of cancer death worldwide.
Eligibility Criteria
Inclusion Criteria: * mCRC with indication for palliative chemotherapy * scheduled for treatment with first-line doublet or triplet chemotherapy, according to the national guideline * able and willing to give written informed consent. Exclusion Criteria: * life expectancy \<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, alcohol addiction); * presence of other disabling co-morbidities that might hamper physical exercise (e.g. heart failure (NYHA classes 3 and 4), chronic obstructive pulmonary disease (COPD, gold 3 and 4), orthopaedic conditions and neurological disorders (e.g., hernia, paresis, amputation, active rheumatoid arthritis); * insufficient mastery of the Dutch language; * presence of serious cardiovascular or cardiopulmonary conditions (e.g. unstable angina, arrhythmia or valve disease) such that exercise safety is at risk, as judged by the treating physician. * Already participating in structured vigorous aerobic and/or resistance exercise ≥ 2 times per week comparable to our intervention
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04754672 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04754672 currently recruiting?
Yes, NCT04754672 is actively recruiting participants. Contact the research team at laurien.buffart@radboudumc.nl for enrollment information.
Where is the NCT04754672 trial being conducted?
This trial is being conducted at 's-Hertogenbosch, Netherlands, Almere Stad, Netherlands, Amersfoort, Netherlands, Amstelveen, Netherlands and 9 additional locations.
Who is sponsoring the NCT04754672 clinical trial?
NCT04754672 is sponsored by Radboud University Medical Center. The trial plans to enroll 228 participants.
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