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

NCT06414122 | Not Yet Recruiting

• 1 other identifier: 22-1294
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oesophageal Cancer; Gastric Cancer; Duodenal Cancer; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Body composition

  Baseline and week 12

• Performance Status

  Baseline and week 12

• Endurance capacity

  Baseline and week 12

• Lower limb performance

  Baseline and week 12

• Upper limb performance

  Baseline and week 12

Study Arms (2)

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

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

Other: conventional exercise training; Other: nutritional therapy

Interventions

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

WB-EMS

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

CONTROL

nutritional therapy OTHER

conventional nutritional counselling with guidelines and digital nutritional coaching

CONTROL; WB-EMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO)

Cologne, North Rhine-Westphalia, 50937, Germany

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Duodenal Neoplasms; Colorectal Neoplasms

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Duodenal Diseases; Intestinal Diseases; Colonic Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Freerk T Baumann, Univ.-Prof.

  Universitätsklinikum Köln

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helen Schörghofer

CONTACT

+49221478; helen.schoerghofer@uk-koeln.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Helen Schörghofer

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

DE (1)