Clinical trial NCT04906954: Effects of Combining a Neuromuscular Electrical Stimulation Intervention With Nutritional Support in Deconditioned Patients With Advanced Gastrointestinal Cancer
Official title: Effects of Combining a Neuromuscular Electrical Stimulation Intervention With Nutritional Support in Deconditioned Patients With Advanced Gastrointestinal Cancer - DIG'ELECTROSTIM-01
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer Digestive
Keywords: electrostimulation
Lead sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase II
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: Step 1 : Number of patients who completed the neuromuscular electrical stimulation (NMES) program
timeFrame: At 6 months
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
timeFrame: Up to 24 months
Secondary outcomes:
measure: Time between inclusion and the observation of the first deterioration of at least 10 points as compared to the baseline score
timeFrame: Up to 24 months
measure: Progression-free survival (PFS)
timeFrame: Up to 24 months
measure: Overall Survival (OS)
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Saint-Cloud
country: France
facility: Insitut Curie
Study officials:
affiliation: Institut Curie Site Saint Cloud
name: Cindy NEUZILLET, MD
role: PRINCIPAL_INVESTIGATOR
References: