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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.
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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cindy NEUZILLET, MD | Institut Curie Site Saint Cloud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Insitut Curie | Saint-Cloud | France |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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Phase II
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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 |
| D005767 |
| Gastrointestinal Diseases |