rectal and oesophageal cancer
Conditions
Interventions
Participants will be randomized in one of three study arms: 1) AE + RE - group
combined moderate-to-high intensity aerobic exercise (AE) and resistance
exercise (RE) twice a week supervised by a specially trained first-line
physiotherapist, and a home-based moderate intensity
2) ExPR - group
in-hospital exercise intervention consisting of
30 min moderate intensity aerobic exercise within one hour prior to every
radiotherapy session (five times a week)
and 3) UC - group
a control group
that receives usual care.
Sponsors
Fysiologie
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Diagnosed with rectal or esophageal carcinoma - Patients with rectal or esophageal carcinoma need to be scheduled for treatment with neoadjuvant chemoradiation therapy • Oral capecitabine combined with concurrent radiotherapy (50 Gy in 25 fractions) for rectal cancer • CROSS regimen (carboplatin, paclitaxel with concurrent 41.4 Gy in 23 fractions radiation) for esophageal cancer - Aged > 18 years
Exclusion criteria
Exclusion criteria: A participant who meets any of the following criteria will be excluded from participation in this study: - Unable to perform basic activities of daily living such as walking or biking - Presence of other disabling co-morbidity that might hamper or endanger physical exercise e.g. heart failure, chronic obstructive pulmonary disease, orthopaedic conditions and neurological disorders - Presence of cognitive disorders or severe emotional instability (e.g., Schizophrenia, Alzheimer, alcohol addiction) - Immunodeficiency (primary or secondary) - Insufficient mastery of the Dutch language - Participation in another exercise and/or dietary intervention study at the same time. Participation in Fit4Surgery is allowed as this starts after NCRT and we have alighted the logistics. - Already participating in structured vigorous aerobic and/or resistance exercise >= 2 times per week comparable to our intervention and planning to continue this throughout the period of neoadjuvant chemoradiation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters will be the feasibility in terms of trial participation rate and attendance, and intervention fidelity (e.g. extend of and reasons for adaptations to the exercise intervention). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters are the average effect sizes and measures of variability on immune function, infiltration, vascularisation, and composition and function of the microbiome. Measurements will take place at baseline, directly after finishing NCRT, and within a week before surgery. | — |
Countries
Netherlands
Outcome results
None listed