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

NCT ID: NCT06414122

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oesophageal Cancer Gastric Cancer Duodenal Cancer Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

WB-EMS

Intervention group receives multimodal therapy with whole-body electromyostimulation and exercise therapy (WB-EMS) as well as conventional nutritional counseling with guidelines and digital nutritional coaching

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

nutritional therapy

Intervention Type OTHER

conventional nutritional counselling with guidelines and digital nutritional coaching

CONTROL

Control group receives multimodal therapy with moderate conventional exercise training in a group and conventional nutritional counselling with guidelines and digital nutritional coaching

Group Type ACTIVE_COMPARATOR

conventional exercise training

Intervention Type OTHER

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

nutritional therapy

Intervention Type OTHER

conventional nutritional counselling with guidelines and digital nutritional coaching

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type OTHER

nutritional therapy

conventional nutritional counselling with guidelines and digital nutritional coaching

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Cologne

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Helen Schörghofer

Helen Schörghofer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Freerk T Baumann, Univ.-Prof.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Köln

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO)

Cologne, North Rhine-Westphalia, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Helen Schörghofer

Role: CONTACT

+49221478 ext. 42646

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Helen Schörghofer

Role: primary

+49221478 ext. 42646

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

22-1294

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.