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Trial Title:
Modulated Mid-frequency Whole-body Electromyostimulation and Nutritional Therapy in Gastrointestinal Cancer Patients
NCT ID:
NCT06414122
Condition:
Oesophageal Cancer
Gastric Cancer
Duodenal Cancer
Colorectal Cancer
Conditions: Official terms:
Duodenal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
mid-frequency whole-body electromyostimulation (WB-EMS)
Description:
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
Arm group label:
WB-EMS
Intervention type:
Other
Intervention name:
conventional exercise training
Description:
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
Arm group label:
CONTROL
Intervention type:
Other
Intervention name:
nutritional therapy
Description:
conventional nutritional counselling with guidelines and digital nutritional coaching
Arm group label:
CONTROL
Arm group label:
WB-EMS
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.
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.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO)
Address:
City:
Cologne
Zip:
50937
Country:
Germany
Contact:
Last name:
Helen Schörghofer
Phone:
+49221478
Phone ext:
42646
Email:
helen.schoerghofer@uk-koeln.de
Start date:
September 2024
Completion date:
September 2026
Lead sponsor:
Agency:
University of Cologne
Agency class:
Other
Source:
University of Cologne
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06414122
