ExeNTrO: Exercise During Neoadjuvant Chemoradiation Treatment to Improve Rectal and Esophageal Cancer Outcome - Pilot Trial

The goals of this study is to 1) evaluate feasibility and fidelity of a three-arm RCT containing a twice-weekly exercise intervention supervised by a first-line (oncology) physiotherapist and a 5-day weekly in-hospital exercise intervention versus usual care in patients with rectal cancer or esophageal cancer receiving NCRT, and 2) generate preliminary data on the variability in exercise responses on immune function, immune infiltration, and vascularisation of the tumour. 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 aerobic exercise session once a week; 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. 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). The secondary study parameters are the average effect sizes and measures of variability on immune function, infiltration and vascularisation. Measurements will take place at baseline, directly after finishing NCRT, and within a week before surgery.

Sex

Female

Minimum age

18 Years

Inclusion Criteria:

* Diagnosed with rectal or esophageal cancer
* Patients with rectal or esophageal cancer 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
* Provided written informed-consent

Exclusion Criteria:

* 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.
* 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.