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NCT06414122 | NOT YET RECRUITING | Oesophageal Cancer

Modulated Mid-frequency Whole-body Electromyostimulation and Nutritional Therapy in Gastrointestinal Cancer Patients
Sponsor:

University of Cologne

Information provided by (Responsible Party):

Helen Schörghofer

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.

Condition or disease

Oesophageal Cancer

Gastric Cancer

Duodenal Cancer

Colorectal Cancer

Intervention/treatment

mid-frequency whole-body electromyostimulation (WB-EMS)

conventional exercise training

nutritional therapy

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 88 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
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)
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2026-09
Estimated Study Completion Date : 2026-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)
Modulated Mid-frequency Whole-body Electromyostimulation and Nutritional Therapy in Gastrointestinal Cancer Patients

Location Details

NCT06414122

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Germany, NRW

University Hospital Cologne, Center for Integrated Oncology (CIO)

Cologne, NRW, Germany, 50937