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

GERCOR - Multidisciplinary Oncology Cooperative Group

Status: Withdrawn

Conditions: Cancer Digestive

Treatments: Other: NMES

Study type: Interventional

Funder types: Other

Identifiers

NCT04906954

DIG' ELECTROSTIM-01-G-097

Details and patient eligibility

About

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

Full 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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Neuromuscular electrical stimulation (NMES)

Other group

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.

Treatment:

Other: NMES