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NCT Number: NCT06414122

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO)

Cologne, North Rhine-Westphalia, 50937, Germany

Location contact

Helen Schörghofer

CONTACT

[email protected]

+49221478 ext. 42646

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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 Training

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

Other

conventional nutritional counselling with guidelines and digital nutritional coaching

Primary outcomes

  1. Muscle mass of the quadriceps muscle

    Time frame: Baseline and week 12

    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.

Secondary outcomes

  1. Body composition

    Time frame: Baseline and week 12

    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)

  2. Performance Status

    Time frame: Baseline and week 12

    Performance Status, with the help of Karnofsky Index (range 0 - 100, higher = better)

  3. Endurance capacity

    Time frame: Baseline and week 12

    Endurance capacity, using spiroergometry measuring maximal oxygen uptake (VO2 max) (higher = better)

  4. Lower limb performance

    Time frame: Baseline and week 12

    Lower limb performance, using 1 minute sit-to-stand test (higher = better)

  5. Upper limb performance

    Time frame: Baseline and week 12

    Upper limb performance, using hand grip strength dynamometry (higher = better)

  6. Fatigue

    Time frame: Baseline and week 12

    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)

  7. health-related Quality of life

    Time frame: Baseline and week 12

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Helen Schörghofer

CONTACT

[email protected]

+49221478 ext. 42646

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study 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)

Acronym: MOMENT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 16, 2024
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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