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

May 17, 2024 updated by: Helen Schörghofer, University of Cologne

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • NRW
      • Cologne, NRW, Germany, 50937
        • Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CONTROL
Control group receives multimodal therapy with moderate conventional exercise training in a group and conventional nutritional counselling with guidelines and digital nutritional coaching
Other: nutritional therapy
conventional nutritional counselling with guidelines and digital nutritional coaching
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
Experimental: 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
Other: nutritional therapy
conventional nutritional counselling with guidelines and digital nutritional coaching
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and week 12

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Investigators

  • Principal Investigator: Freerk T Baumann, Univ.-Prof., Universitätsklinikum Köln

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

May 10, 2024

First Submitted That Met QC Criteria

May 10, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 20, 2024

Last Update Submitted That Met QC Criteria

May 17, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-1294

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

Beginning 6 months and ending 24 months after article publication

IPD Sharing 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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