Aerobic Fitness or Muscle Mass Training to Improve Colorectal Cancer Outcome

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.

Conditions

• Colorectal Cancer
• Chemotherapeutic Toxicity
• Survivorship
• Lifestyle

Interventions

BEHAVIORAL

Continuous aerobic and resistance exercise intervention

Continuous aerobic and resistance exercises intervention

BEHAVIORAL

Continuous aerobic and aerobic interval exercise intervention

Continuous aerobic and aerobic interval exercise intervention

Sponsors & Collaborators

• UMC Utrecht

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Rijnstate Hospital

  collaborator OTHER

• Jeroen Bosch Ziekenhuis

  collaborator OTHER

• Flevoziekenhuis

  collaborator OTHER

• Catharina Ziekenhuis Eindhoven

  collaborator OTHER

• Meander Medical Center

  collaborator OTHER

• Ziekenhuis Amstelland

  collaborator OTHER

• Amphia Hospital

  collaborator OTHER

• Spaarne Gasthuis

  collaborator OTHER

• Canisius-Wilhelmina Hospital

  collaborator OTHER

• Amsterdam UMC, location VUmc

  collaborator OTHER

• The Netherlands Cancer Institute

  collaborator OTHER

• Radboud University Medical Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-02

Primary Completion

2026-03-31

Completion

2026-12-31

Countries

• Netherlands

Study Locations