Clinical trial · Interventional
Combined Neuromuscular Electrical Stimulation and Nutritional Support for Advanced Gastrointestinal Cancer Patients.
Effects of Combining a Neuromuscular Electrical Stimulation Intervention With Nutritional Support in Deconditioned Patients With Advanced Gastrointestinal Cancer - DIG'ELECTROSTIM-01
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was not initiated due to logistical challenges, and the contract for the acquisition of the equipment-comprising relatively high-cost machinery-was never finalized.
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Digestive | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NMES | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Neuromuscular electrical stimulation (NMES)
- description
- 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.
- interventionNames
- Other: NMES
Primary outcomes (2)
- measure
- Step 1 : Number of patients who completed the neuromuscular electrical stimulation (NMES) program
- timeFrame
- At 6 months
- description
- Step 1: Feasibility study will be performed on the first 10 patients. The NMES adherence will be satisfactory if the patient achieves ≥ 40% of planned sessions (12 in total). The NMES will be considered feasible if ≥ 70% of the first 10 patients included achieve this goal.
- measure
- Step 2 : Number of patients with improvement of 10 points between baseline and week 8, assessed using the EORTC QLQ-C30 physical functioning scale
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available