Combined Neuromuscular Electrical Stimulation and Nutritional Support for Advanced Gastrointestinal Cancer Patients.

NCT ID: NCT04906954

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2024-12-31

Brief Summary

Dig' Electrostim-01 is phase II, single center (step 1) and multicentre (step 2), single-arm study to evaluate an 8-week NMES intervention combined with nutritional support in addition to usual patient care

Detailed Description

Sarcopenia and cachexia are observed in more than 50% of patients with gastrointestinal (GI) cancer.

Both negatively affect patient survival and health-related quality of life (HRQoL) due to decreased tolerance to anticancer treatments and increased susceptibility to infections and other complications. Therefore, sarcopenia and cachexia represent a major clinical issue in this setting. A multimodal therapeutic approach to the sarcopenia and cachexia management is recommended, including nutritional support and exercise with personalized oncology care and family-centered education.

Neuromuscular electrical stimulation (NMES) generates muscle contractions using portable devices connected to surface electrodes.

NMES is safe, does not require the active cooperation of the patient and can be self-administered at home, thereby providing an acceptable physical therapy for patients with advanced cancer and an altered Eastern Cooperative Oncology Group performance status (ECOG PS) and/or a high-symptom burden, for whom attendance to hospital-based exercise training is difficult.

In this study, we hypothesize that NMES is a safe and effective physical-therapy strategy to improve HRQoL and to reduce cancer-induced sarcopenia in patients with metastatic GI cancer and altered ECOG PS (ECOG PS of 2).

Conditions

Cancer Digestive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Neuromuscular electrical stimulation (NMES)

30 NMES sessions will be performed by patients for 30 min, for a period of 8 weeks, according to a standardized protocol.

The number of sessions per week will be gradually increased to reach 5 sessions/week at week 4.

Group Type: OTHER

NMES

Intervention Type: OTHER

Standardized strength program (75 Hz frequency, 40 cycles). The stimulation intensity will be increased up to the highest tolerated level in order to evoke strong muscle contractions.

Interventions

NMES

Standardized strength program (75 Hz frequency, 40 cycles). The stimulation intensity will be increased up to the highest tolerated level in order to evoke strong muscle contractions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Signed and dated informed consent,

2. Age ≥ 18 years,

3. Mini Nutritional Assessment (MNA) and geriatric 8 (G8) health status screening tools for patients ≥ 70 years and oncogeriatric evaluation if G8 ≤ 14,

4. First-line chemotherapy for advanced disease,

5. Histologically confirmed colorectal, pancreatic, esophageal, or gastric cancer (adenocarcinoma or squamous cell carcinoma),

6. Metastatic disease not amenable to surgery, radiation, or combined modality therapy with curative intent (previous resection of primary tumor allowed),

7. Patients able to receive chemotherapy,

8. Eastern Cooperative Oncology Group performance status of 2,

9. Life expectancy ≥ 3 months,

10. Registration in a National Health Care System (Protection Universelle Maladie [PUMa] included).

Exclusion Criteria

1. Neuroendocrine histology or primary tumor other than esophageal, gastric, pancreatic, biliary, or colorectal cancer,

2. Any medical (including psychiatric, musculoskeletal, or neurological) condition contra-indicating exercise practice,

3. Ulcerative skin lesions over the quadriceps muscle,

4. Participation to another physical activity program (exercise or NMES),

5. Pacemaker-depended patients,

6. Albuminemia < 25 g/L,

7. Pregnancy or breastfeeding,

8. Protected adults (individuals under guardianship by court order or tutelage). Note: participation to another concomitant clinical trial (except for trials evaluating exercise or NMES programs) is allowed, but the patient must inform about it and get an authorization from the Investigator.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cindy NEUZILLET, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Curie Site Saint Cloud

Locations

Insitut Curie

Saint-Cloud, , France

Countries

France

Other Identifiers

DIG' ELECTROSTIM-01-G-097

Identifier Type: -

Identifier Source: org_study_id