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

NCT04906954 | Withdrawn

• 1 other identifier: DIG' ELECTROSTIM-01-G-097
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Cancer Digestive

Keywords

electrostimulation

Outcome Measures

Primary Outcomes (2)

• Step 1 : Number of patients who completed the neuromuscular electrical stimulation (NMES) program

  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.

  At 6 months

• Step 2 : Number of patients with improvement of 10 points between baseline and week 8, assessed using the EORTC QLQ-C30 physical functioning scale

  At baseline, at week 8

  Up to 24 months

Secondary Outcomes (3)

• Time between inclusion and the observation of the first deterioration of at least 10 points as compared to the baseline score

  Up to 24 months

• Progression-free survival (PFS)

  Up to 24 months

• Overall Survival (OS)

  Up to 24 months

Study Arms (1)

Neuromuscular electrical stimulation (NMES)

OTHER

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.

Other: NMES

Interventions

NMES 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.

Neuromuscular electrical stimulation (NMES)

Eligibility Criteria

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

You may qualify if:

• Signed and dated informed consent,
• Age ≥ 18 years,
• Mini Nutritional Assessment (MNA) and geriatric 8 (G8) health status screening tools for patients ≥ 70 years and oncogeriatric evaluation if G8 ≤ 14,
• First-line chemotherapy for advanced disease,
• Histologically confirmed colorectal, pancreatic, esophageal, or gastric cancer (adenocarcinoma or squamous cell carcinoma),
• Metastatic disease not amenable to surgery, radiation, or combined modality therapy with curative intent (previous resection of primary tumor allowed),
• Patients able to receive chemotherapy,
• Eastern Cooperative Oncology Group performance status of 2,
• Life expectancy ≥ 3 months,
• Registration in a National Health Care System (Protection Universelle Maladie \[PUMa\] included).

You may not qualify if:

• Neuroendocrine histology or primary tumor other than esophageal, gastric, pancreatic, biliary, or colorectal cancer,
• Any medical (including psychiatric, musculoskeletal, or neurological) condition contra-indicating exercise practice,
• Ulcerative skin lesions over the quadriceps muscle,
• Participation to another physical activity program (exercise or NMES),
• Pacemaker-depended patients,
• Albuminemia \< 25 g/L,
• Pregnancy or breastfeeding,
• 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.

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead

Study Sites (1)

Insitut Curie

Saint-Cloud, France

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Cindy NEUZILLET, MD

  Institut Curie Site Saint Cloud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase II

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: September 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)