Oesophageal CancerMOMENTNCT06414122
Modulated Mid-frequency Whole-body Electromyostimulation and Nutritional Therapy in Gastrointestinal Cancer Patients
A study testing mid-frequency whole-body electromyostimulation (WB-EMS), conventional exercise training and nutritional therapy in people with Oesophageal Cancer and Gastric Cancer, run by University of Cologne at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oesophageal Cancer, Gastric Cancer, Duodenal Cancer
- What is being tested?
- mid-frequency whole-body electromyostimulation (WB-EMS), conventional exercise training and nutritional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2026to Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO)
Cologne, North Rhine-Westphalia, 50937
Helen Schörghofer, +49221478 ext. 42646, helen.schoerghofer@uk-koeln.de
About this study
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)
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.
Read the 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.
- Conditions
- Oesophageal Cancer, Gastric Cancer, Duodenal Cancer, Colorectal Cancer
- Being tested
- mid-frequency whole-body electromyostimulation (WB-EMS), conventional exercise training, nutritional therapy
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Duodenal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mid-frequency whole-body electromyostimulation (WB-EMS)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
conventional exercise trainingOther
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 therapyOther
conventional nutritional counselling with guidelines and digital nutritional coaching
| Study group | Role | What they receive |
|---|---|---|
| WB-EMS | Experimental | 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 Receives: Other: mid-frequency whole-body electromyostimulation (WB-EMS); Other: nutritional therapy |
| CONTROL | Active comparator | Control group receives multimodal therapy with moderate conventional exercise training in a group and conventional nutritional counselling with guidelines and digital nutritional coaching Receives: Other: conventional exercise training; Other: nutritional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 12
Secondary outcomes (7)
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)
Measured: Baseline and week 12
Performance Status
Performance Status, with the help of Karnofsky Index (range 0 - 100, higher = better)
Measured: Baseline and week 12
Endurance capacity
Endurance capacity, using spiroergometry measuring maximal oxygen uptake (VO2 max) (higher = better)
Measured: Baseline and week 12
Lower limb performance
Lower limb performance, using 1 minute sit-to-stand test (higher = better)
Measured: Baseline and week 12
Upper limb performance
Upper limb performance, using hand grip strength dynamometry (higher = better)
Measured: 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)
Measured: 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)
Measured: Baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Aug 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oesophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Schörghofer, University of Cologne
- Investigators
- Freerk T Baumann, Univ.-Prof., Principal investigator, Universitätsklinikum Köln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414122
- Sponsor's protocol ID
- 22-1294
- Acronym
- MOMENT
- Status last verified
- Jul 2026
- First submitted
- 10 May 2024
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication