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

Primary Purpose

Cancer Digestive

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
NMES
Sponsored by
GERCOR - Multidisciplinary Oncology Cooperative Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer Digestive focused on measuring electrostimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Insitut Curie

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Neuromuscular electrical stimulation (NMES)

Arm 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.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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
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
Overall Survival (OS)
OS defined as the time between inclusion and death (from all causes)

Full Information

First Posted
May 25, 2021
Last Updated
June 11, 2021
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT04906954
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 29, 2021 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Digestive
Keywords
electrostimulation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Phase II
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neuromuscular electrical stimulation (NMES)
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
NMES
Intervention Description
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.
Primary Outcome Measure Information:
Title
Step 1 : Number of patients who completed the neuromuscular electrical stimulation (NMES) program
Description
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.
Time Frame
At 6 months
Title
Step 2 : Number of patients with improvement of 10 points between baseline and week 8, assessed using the EORTC QLQ-C30 physical functioning scale
Description
At baseline, at week 8
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Time between inclusion and the observation of the first deterioration of at least 10 points as compared to the baseline score
Description
Every 2 moths until 12 months after inclusion
Time Frame
Up to 24 months
Title
Progression-free survival (PFS)
Description
PFS defined as the time between inclusion and tumor progression (according to RECIST v1.1) or death (all causes), whichever occurs first
Time Frame
Up to 24 months
Title
Overall Survival (OS)
Description
OS defined as the time between inclusion and death (from all causes)
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Line GARCIA LARNICOL, MD
Phone
+33 (01) 40 29 85 00
Email
gercor@gercor.com.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cindy NEUZILLET, MD
Organizational Affiliation
Institut Curie Site Saint Cloud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Insitut Curie
City
Saint-Cloud
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cindy Neuzillet, MD
First Name & Middle Initial & Last Name & Degree
Cindy NEUZILLET, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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