Effects of Combining a Neuromuscular Electrical Stimulation Intervention With Nutritional Support in Deconditioned Patients With Advanced Gastrointestinal Cancer

Effects of Combining a Neuromuscular Electrical Stimulation Intervention With Nutritional Support in Deconditioned Patients With Advanced Gastrointestinal Cancer - DIG'ELECTROSTIM-01

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer Digestive
• Intervention / Treatment: Other: NMES

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).

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie-Line GARCIA LARNICOL, MD; Phone Number: +33 (01) 40 29 85 00; Email: gercor@gercor.com.fr

Study Locations

• France
  • Saint-Cloud, France
    • Insitut Curie
    • Principal Investigator: Cindy NEUZILLET, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time between inclusion and the observation of the first deterioration of at least 10 points as compared to the baseline score	Every 2 moths until 12 months after inclusion	Up to 24 months
Progression-free survival (PFS)	PFS defined as the time between inclusion and tumor progression (according to RECIST v1.1) or death (all causes), whichever occurs first	Up to 24 months
Overall Survival (OS)	OS defined as the time between inclusion and death (from all causes)	Up to 24 months

Collaborators and Investigators

• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
• Investigators: Principal Investigator: Cindy NEUZILLET, MD, Institut Curie Site Saint Cloud

Study record dates

Study Major Dates

• Study Start (Anticipated): June 29, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: electrostimulation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: DIG' ELETROSTIM-01 - G-097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No