Modulated Mid-frequency Whole-body Electromyostimulation and Nutritional Therapy in Gastrointestinal Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mid-frequency whole-body electromyostimulation (WB-EMS), conventional exercise training, nutritional therapy.
- Who it may be relevant to
- Registry conditions: Oesophageal Cancer, Gastric Cancer, Duodenal Cancer, Colorectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
The purpose of this study is to assess the efficacy of modulated mid-frequency whole-body electromyostimulation (WB-EMS) combined with nutritional therapy in patients with gastrointestinal cancer.
Detailed description
This study aims to combine the applicability and effectiveness of a form of strength training with targeted nutritional training. For this purpose, training with electromyostimulation (application of modulated mid-frequency; WB-EMS) is carried out, which pursues the effect of cell activation and the improvement of muscle strength. The primary aim of the multimodal intervention presented here is to increase muscle mass and improve energy utilisation and metabolism. Patients should experience increased mobility and independence as a result of this intervention. In the study, patients are randomly assigned to one of two groups, with one group receiving an application of electricity and the other group performing standardised exercise therapy without electricity. Otherwise, the groups do not differ in the applications or tests. In addition, nutritional coaching takes place in both groups with digital nutritional coaching.
Patients with a malignant tumour of the oesophagus, stomach, duodenum or colon or rectum with medical therapy administered before or after surgery (neoadjuvant and adjuvant therapy) and after surgery without further therapy can participate in the study.
The aim is to compare the use of electromyostimulation in this multimodal approach regarding its effectiveness in terms of muscle growth compared to the conventional multimodal approach. The research hypothesis is that the additional training stimulus provided by the application of electricity leads to significantly higher muscle growth than conventional training without electricity.
Interventions
- Other mid-frequency whole-body electromyostimulation (WB-EMS)
supervised group training sessions at least once and optionally twice a week, lasting 11-20 minutes, over 12 weeks, 12-24 training sessions in total - Other conventional exercise training
supervised group training at least once a week, optional additional home-based training once a week, lasting 40 minutes, over 12 weeks, 12-24 training sessions in total - Other nutritional therapy
conventional nutritional counselling with guidelines and digital nutritional coaching
Primary outcome measures
- Muscle mass of the quadriceps muscle [Time frame: Baseline and week 12]
Secondary outcome measures (7)
- Body composition [Time frame: Baseline and week 12]
- Performance Status [Time frame: Baseline and week 12]
- Endurance capacity [Time frame: Baseline and week 12]
- Lower limb performance [Time frame: Baseline and week 12]
- Upper limb performance [Time frame: Baseline and week 12]
- Fatigue [Time frame: Baseline and week 12]
- health-related Quality of life [Time frame: Baseline and week 12]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Germany · 1 center
- Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO) — Cologne
Identifiers
NCT: NCT06414122 · 22-1294