The efficacy of modulated mid-frequency (whole-body electromyostimulation) and nutritional therapy in patients with solid tumors of the gastrointestinal tract (excluding liver and pancreatic carcinomas)

Not Applicable

Conditions: Solid tumours of the oesophagus, stomach, duodenum or colon or rectum

Registration Number: DRKS00033966

Lead Sponsor: Dreifaltigkeits-Krankenhaus Wesseling

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 88

Inclusion Criteria

Patients with oesophageal, gastric, duodenal, colon or rectal cancer following surgery without further therapy and with neoadjuvant and adjuvant therapy
- medical clearance for exercise training
- written declaration of consent from the study participant

Exclusion Criteria

- Participation in another study on the topic of exercise or nutrition
- Electronic implants such as pacemakers, pumps, and coronary stents
- Cardiac arrhythmia
- Implants in the area of application (e.g. breast implants)
- Pregnancy
- Epilepsy
- Wounds and open skin diseases in the area of application of the electrodes
- Unhealed operations or bone fractures
- Acute inflammatory diseases (e.g. inflammation of the intervertebral discs, bones, vessels, or soft tissue)
- Directly after herniated discs or other instabilities such as large abdominal wall hernias
- Blood clots (thromboses)
- Bone diseases with high-grade osteoporosis
- Increased risk of haemorrhage
- Fever and illnesses that can be aggravated by physical exertion
- Untreated high blood pressure
- Blindness
- Continuous parenteral nutrition
- Metal and electronic parts in the body (e.g. prostheses, metal vascular clips, hearing aids/inner ear/cochlear implants, magnetic dental prostheses, pacemakers, contraceptives)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Muscle mass of the quadriceps muscle (vastus lateralis / rectus femoris) (CSD using ultrasound), T0 baseline & T1 after 12 weeks

Secondary Outcome Measures

Name	Time	Method
Body composition, using bioimpedance analysis (BIA), T0 baseline & T1 after 12 weeks<br>Performance status, with the help of Karnofsky index, T0 baseline & T1 after 12 weeks<br>Endurance capacity, using spiroergometry, T0 baseline & T1 after 12 weeks<br>Lower limb and upper limb performance, using sit-to-stand test (1 minute) and hand grip strength (dynamometry), T0 baseline & T1 after 12 weeks<br>Fatigue symptoms, using the 13-item FACIT Fatigue Scale, T0 baseline & T1 after 12 weeks<br>Quality of life, using the EORTC QLQ C-30, T0 baseline & T1 after 12 weeks<br>Blood parameters, venous blood sampling (routine examination) as part of oncological aftercare, T0 baseline & T1 after 12 weeks