Exercise during Neoadjuvant chemoradiation Treatment to improve rectal and esophageal cancer Outcome - pilot trial.

Phase 2

Recruiting

Conditions: rectal and oesophageal cancer
10017991

Registration Number: NL-OMON53636

Lead Sponsor: Fysiologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 39

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters will be the feasibility in terms of trial<br /><br>participation rate and attendance, and intervention fidelity (e.g. extend of<br /><br>and reasons for adaptations to the exercise intervention). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters are the average effect sizes and measures of<br /><br>variability on immune function, infiltration, vascularisation, and composition<br /><br>and function of the microbiome. Measurements will take place at baseline,<br /><br>directly after finishing NCRT, and within a week before surgery. </p><br>