Clinical trial NCT06414122: Modulated Mid-frequency Whole-body Electromyostimulation and Nutritional Therapy in Gastrointestinal Cancer Patients
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Oesophageal Cancer
Gastric Cancer
Duodenal Cancer
Colorectal Cancer
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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)

Primary outcomes:
measure: Muscle mass of the quadriceps muscle
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Body composition
timeFrame: Baseline and week 12
measure: Performance Status
timeFrame: Baseline and week 12
measure: Endurance capacity
timeFrame: Baseline and week 12
measure: Lower limb performance
timeFrame: Baseline and week 12
measure: Upper limb performance
timeFrame: Baseline and week 12
measure: Fatigue
timeFrame: Baseline and week 12
measure: health-related Quality of life
timeFrame: Baseline and week 12
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO)
state: NRW
Study officials:
affiliation: Universitätsklinikum Köln
name: Freerk T Baumann, Univ.-Prof.
role: PRINCIPAL_INVESTIGATOR
References: