An interventional study of mid-frequency whole-body electromyostimulation (WB-EMS) and conventional exercise training in Oesophageal Cancer, Gastric Cancer and Duodenal Cancer, sponsored by University of Cologne. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by University of Cologne · Not applicable, Interventional, and Supportive care
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.
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.
1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.
This study's planned enrollment of 88 is above the median of 58 across 1,347 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →University of Cologne is the lead sponsor of 203 studies on the registry; 26 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: mid-frequency whole-body electromyostimulation (WB-EMS) · Other: nutritional therapy
Control group receives multimodal therapy with moderate conventional exercise training in a group and conventional nutritional counselling with guidelines and digital nutritional coaching
Other: conventional exercise training · Other: nutritional therapy
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
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
conventional nutritional counselling with guidelines and digital nutritional coaching
Muscle mass of the quadriceps muscle
Muscle mass of the quadriceps muscle (vastus lateralis / rectus femoris), cross-sectional diameter (CSD) using ultrasound. Muscle ultrasound represents a cheap and user-friendly, yet robust and reliable, method to monitor muscle mass.
Time frame: Baseline and week 12
Body composition
Body composition including skeletal muscle mass, fat free mass, fat mass, total body water, body cell mass and extracellular mass, using bioimpedance analysis (BIA) (Nutriguard-MS)
Time frame: Baseline and week 12
Performance Status
Performance Status, with the help of Karnofsky Index (range 0 - 100, higher = better)
Time frame: Baseline and week 12
Endurance capacity
Endurance capacity, using spiroergometry measuring maximal oxygen uptake (VO2 max) (higher = better)
Time frame: Baseline and week 12
Lower limb performance
Lower limb performance, using 1 minute sit-to-stand test (higher = better)
Time frame: Baseline and week 12
Upper limb performance
Upper limb performance, using hand grip strength dynamometry (higher = better)
Time frame: Baseline and week 12
Fatigue
Fatigue symptoms, using the 13-item Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT Fatigue Scale). The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact on daily activities and function. Score range 0-52 (higher = better)
Time frame: Baseline and week 12
health-related Quality of life
Quality of life, using the EORTC QLG Core Questionnaire (EORTC QLQ-C30). The EORTC QLQ-C30 is a 30-item instrument meant to assess some of the different aspects that define the quality of life of cancer patients. Score range 0-100 (higher = better)
Time frame: Baseline and week 12
Plan to share: Yes — All IPD that underlie results in a publication
Time frame: Beginning 6 months and ending 24 months after article publication
Access criteria: IPD will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to helen.schoerghofer@uk-koeln.de. To gain access, data requestors will need to sign a data access agreement.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Aug 2028, 24 months later.
Of 209 non-industry interventional studies with no phase under Esophageal Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 96. This study's planned 24 months is below that.
Counting every sponsor, half of 218 studies reached it within 46 months; a quarter within 23 and three quarters within 96.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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