## Protocol Section
### Identification Module
**NCT ID:** NCT06414122

**Acronym:** MOMENT

**Brief Title:** Modulated Mid-frequency Whole-body Electromyostimulation and Nutritional Therapy in Gastrointestinal Cancer Patients

**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)

#### Organization Study ID Info
**ID:** 22-1294
#### Organization
**Class:** OTHER
**Full Name:** University of Cologne
### Status Module
#### Completion Date
**Date:** 2026-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Cologne

#### Responsible Party

**Investigator Affiliation:** University of Cologne

**Investigator Full Name:** Helen Schörghofer

**Investigator Title:** Helen Schörghofer

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Oesophageal Cancer

- Gastric Cancer

- Duodenal Cancer

- Colorectal Cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 88

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Other: mid-frequency whole-body electromyostimulation (WB-EMS)

- Other: nutritional therapy

**Label:** WB-EMS

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Control group receives multimodal therapy with moderate conventional exercise training in a group and conventional nutritional counselling with guidelines and digital nutritional coaching

**Intervention Names:**

- Other: conventional exercise training

- Other: nutritional therapy

**Label:** CONTROL

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 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

**Name:** mid-frequency whole-body electromyostimulation (WB-EMS)

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- CONTROL

**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

**Name:** conventional exercise training

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- CONTROL

- WB-EMS

**Description:** conventional nutritional counselling with guidelines and digital nutritional coaching

**Name:** nutritional therapy

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Muscle mass of the quadriceps muscle

**Time Frame:** Baseline and week 12

#### Secondary Outcomes

**Description:** 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)

**Measure:** Body composition

**Time Frame:** Baseline and week 12

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

**Measure:** Performance Status

**Time Frame:** Baseline and week 12

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

**Measure:** Endurance capacity

**Time Frame:** Baseline and week 12

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

**Measure:** Lower limb performance

**Time Frame:** Baseline and week 12

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

**Measure:** Upper limb performance

**Time Frame:** Baseline and week 12

**Description:** 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)

**Measure:** Fatigue

**Time Frame:** Baseline and week 12

**Description:** 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)

**Measure:** health-related Quality of life

**Time Frame:** Baseline and week 12

### Eligibility Module

**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)

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** helen.schoerghofer@uk-koeln.de

**Name:** Helen Schörghofer

**Phone:** +49221478

**Phone Ext:** 42646

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Cologne

**Contacts:**

***Contact 1:***

- **Email:** helen.schoerghofer@uk-koeln.de

- **Name:** Helen Schörghofer

- **Phone:** +49221478

- **Phone Ext:** 42646

- **Role:** CONTACT

**Country:** Germany

**Facility:** Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO)

**State:** NRW

**Zip:** 50937

#### Overall Officials

**Official 1:**

**Affiliation:** Universitätsklinikum Köln

**Name:** Freerk T Baumann, Univ.-Prof.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**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.

**Description:** All IPD that underlie results in a publication

**IPD Sharing:** YES

**Time Frame:** Beginning 6 months and ending 24 months after article publication

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000004378

- Term: Duodenal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16064

- Name: Stomach Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M13110

- Name: Pancreatic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7553

- Name: Duodenal Neoplasms

- Relevance: HIGH

- As Found: Duodenal Cancer

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7552

- Name: Duodenal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T5486

- Name: Stomach Cancer

- Relevance: LOW

- As Found: Unknown

- ID: T2141

- Name: Esophageal Cancer

- Relevance: HIGH

- As Found: Oesophageal Cancer

- ID: T4387

- Name: Pancreatic Cancer

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004379

- Term: Duodenal Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
