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

Colorectal Cancer Clinical Trial

— MOMENT  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06414122
• Other study ID #: 22-1294
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: September 2026

Study information

• Verified date: May 2024
• Source: University of Cologne
• Contact: Helen Schörghofer
• Phone: +49221478
• Email: helen.schoerghofer[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Cancer
• Duodenal Cancer
• Duodenal Neoplasms
• Gastric Cancer
• Oesophageal Cancer

Intervention

Other:
• 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
• 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
• nutritional therapy
conventional nutritional counselling with guidelines and digital nutritional coaching

Locations

Country	Name	City	State
Germany	Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO)	Cologne	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and week 12
Secondary	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)	Baseline and week 12
Secondary	Performance Status	Performance Status, with the help of Karnofsky Index (range 0 - 100, higher = better)	Baseline and week 12
Secondary	Endurance capacity	Endurance capacity, using spiroergometry measuring maximal oxygen uptake (VO2 max) (higher = better)	Baseline and week 12
Secondary	Lower limb performance	Lower limb performance, using 1 minute sit-to-stand test (higher = better)	Baseline and week 12
Secondary	Upper limb performance	Upper limb performance, using hand grip strength dynamometry (higher = better)	Baseline and week 12
Secondary	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)	Baseline and week 12
Secondary	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)	Baseline and week 12