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

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Jeroen Bosch Ziekenhuis
RECRUITING
's-hertogenbosch
Flevoziekenhuis
RECRUITING
Almere Stad
Meander Medisch Centrum
RECRUITING
Amersfoort
Ziekenhuis Amstelland
RECRUITING
Amstelveen
Amsterdam UMC
RECRUITING
Amsterdam
Netherlands Cancer Institute
RECRUITING
Amsterdam
Rijnstate Ziekenhuis
RECRUITING
Arnhem
Ziekenhuis Amphia
RECRUITING
Breda
Catharina Ziekenhuis
RECRUITING
Eindhoven
Spaarne Gasthuis
RECRUITING
Hoofddorp
Canisius Wilhelmina Ziekenhuis
RECRUITING
Nijmegen
Radboudumc
RECRUITING
Nijmegen
UMCU
RECRUITING
Utrecht
Contact Information
Primary
Laurien M Buffart, PhD
laurien.buffart@radboudumc.nl
+31243613674
Time Frame
Start Date: 2021-03-02
Estimated Completion Date: 2026-12
Participants
Target number of participants: 228
Treatments
Experimental: Continuous aerobic and resistance exercise (AE+RE)
Two 60 min moderate-to-high intensity exercise sessions per week supervised by a physiotherapist.~Continuous aerobic exercise: 15-20 min continuous aerobic exercise (e.g. walking) of moderate intensity (Borg 13-14 'somewhat hard').~Resistance exercise (25 min): 6 exercises targeting large muscle groups vertical row, squat, bench press, pull over, abdominal crunch, and lunge. 2 sets of 10 repetitions at 70-80% of 1 RM. To ensure adequate training load over time, tests are repeated every 3/4 weeks aligned with the chemotherapy cycle.~One additional (third) session from home at moderate intensity for at least 30 min.~A brochure with exercise guidelines is provided.
Experimental: Continuous aerobic and aerobic interval exercise (AE+AI)
Continuous aerobic exercise: 15-20 min continuous aerobic exercise (e.g. walking) of moderate intensity (Borg 13-14 'somewhat hard').~Aerobic interval (25 min): cycling with high intensity intervals alternated with recovery intervals. Intensity of the interval: between 85% and 95% of estimated maximum heart rate, adjusted to Borg 16-18 'hard - very hard'. In between the intervals, light intensity cycling will be performed for active recovery at 30% of Wmax estimated from Steep ramp test and adjusted to Borg \< 12.~One additional (third) session from home at moderate intensity for at least 30 min.~A brochure with exercise guidelines is provided.
No_intervention: Usual care control group
Patients in the usual care group receive care as usual. In addition, a brochure with exercise guidelines for cancer survivors is provided
Authors
H. Verheul
Related Therapeutic Areas
Sponsors
Collaborators: The Netherlands Cancer Institute, Amphia Hospital, Amsterdam UMC, location VUmc, Catharina Ziekenhuis Eindhoven, Flevoziekenhuis, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Ziekenhuis Amstelland, Meander Medical Center, UMC Utrecht, Spaarne Gasthuis, Canisius-Wilhelmina Hospital, Jeroen Bosch Ziekenhuis, Rijnstate Hospital
Leads: Radboud University Medical Center

This content was sourced from clinicaltrials.gov